Real world evidence – The Publication Plan for everyone interested in medical writing, the development of medical publications, and publication planning https://thepublicationplan.com A central online news resource for professionals involved in the development of medical publications and involved in publication planning and medical writing. Wed, 30 Jul 2025 15:54:36 +0000 en-US hourly 1 https://s0.wp.com/i/webclip.png Real world evidence – The Publication Plan for everyone interested in medical writing, the development of medical publications, and publication planning https://thepublicationplan.com 32 32 88258571 Optimising patient journeys to inform strategy and improve patient outcomes https://thepublicationplan.com/2025/07/30/optimising-patient-journeys-to-inform-strategy-and-improve-patient-outcomes/ https://thepublicationplan.com/2025/07/30/optimising-patient-journeys-to-inform-strategy-and-improve-patient-outcomes/#respond Wed, 30 Jul 2025 15:54:34 +0000 https://thepublicationplan.com/?p=18140

KEY TAKEAWAYS

  • Patient journeys should be part of a wider strategy and involve a range of stakeholders.
  • Regular updates are key in ensuring patient journeys stay relevant and continue to reflect real world experiences of patients and caregivers.

Patient journeys can provide the pharmaceutical industry with rich data to inform strategy across product life cycles. In a PMLiVE article, Stephanie Hall and Louise Collins discuss 3 actions the industry can take to optimise patient journeys and unlock their full potential.

Patient journeys should be part of the wider strategy

Hall and Collins recommend integrating patient journeys into wider strategy and life cycle management. Combining quantitative and qualitative aspects provides both measurable data and insights into the real-world issues experienced by patients, carers, and healthcare professionals. This information, they say, can help clarify which areas are the most important.

Gather a diverse team

The authors suggest greater collaboration adds greater depth to patient journeys: bringing together medical, marketing, medical affairs, digital, and analytical stakeholders creates an environment that fosters a broader range of information and ideas. Additionally, including patient advocates and healthcare professionals creates richer information, forges stronger relationships, and uncovers nuances that may otherwise remain hidden.

“Including patient advocates and healthcare professionals creates richer information, forges stronger relationships, and uncovers nuances that may otherwise remain hidden.”

Create and iterate

Patient journeys are dynamic; regular reassessments enable new data and insights to be integrated, ensuring the journey continues to represent real experiences of patients and caregivers. When used creatively, patient journeys can help disrupt standard strategies.

The authors describe the importance of choosing the right format for patient journeys:

  • Data-rich flowcharts may help identify gaps in care.
  • Graphical approaches may allow cross-functional teams to better understand complex interactions.
  • Combining these formats can provide measurable outcomes weaved with emotional context.

The authors conclude that developing and regularly updating thorough patient journeys can stimulate innovation, result in more effective processes, and improve patient outcomes.

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Do you think more detailed patient journeys could improve drug development strategies?

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Meeting report: summary of Day 1 of the 2025 ISMPP European Meeting https://thepublicationplan.com/2025/02/11/meeting-report-summary-of-day-1-of-the-2025-ismpp-european-meeting/ https://thepublicationplan.com/2025/02/11/meeting-report-summary-of-day-1-of-the-2025-ismpp-european-meeting/#respond Tue, 11 Feb 2025 09:17:53 +0000 https://thepublicationplan.com/?p=17163

The 2025 European Meeting of the International Society for Medical Publication Professionals (ISMPP) was held in London on 27–29 January. The meeting, which was themed ‘Core Values for an Integrated Age’, saw a record-breaking 418 delegates in attendance.

A summary of the first day of the meeting is provided below to benefit those who were unable to attend the meeting, and as a timely reminder of the key topics covered for those who did.

Summaries of the second day of the meeting can be found here.

Summaries of Day 1

Chair’s welcome, CMPP update and ISMPP presidential address


KEY TAKEAWAYS

  • Attendance and engagement at ISMPP EU continue to grow, reflecting an active and collaborative community of medical publications professionals.
  • ISMPP’s core values are fundamental as the industry embraces innovation and integrates new technologies.
  • The CMPP programme celebrates 15 years of excellence, with increased global representation and accessibility.

Mithi Ahmed-Richards (Taylor & Francis) opened the 2025 European Meeting of ISMPP, recognising the continued growth of the meeting with increasing numbers of abstract submissions and poster presentations. Acknowledging the collaborative spirit of the medical publications community, she emphasised how ISMPP and its members drive advancements in publication practices and ultimately improve patient care. Noting the meeting’s theme of Core Values for an Integrated Age, Ahmed-Richards stressed that trustworthiness surpasses skill and that core values must be demonstrated through actions.

Ann Gordon (Chair of the ISMPP Certification Board) provided an update on the Certified Medical Publication Professional (CMPP™) programme, which is celebrating 15 years of professional excellence in medical publications this year. The CMPP community has grown to 1,659 professionals across 31 countries, spanning 6 continents, with South America most recently represented. Achievements in 2024 included the launch of the LearningBuilder certification platform, a significant rise in CMPP mentors, and enhanced accessibility through financial assistance for exam fees. Gordon reinforced the value of the CMPP credential in demonstrating expertise, leadership, and ethical publication practices.

Expanding on the meeting’s theme, Rob Matheis (ISMPP President and CEO) emphasised the importance of balancing core values with innovation, citing the need to consider evolving information sources beyond traditional medical journals. He outlined ongoing key initiatives of the society, including patient membership programmes, a renewed presence in the Asia-Pacific region, and the hosting of #MedComms Day. Matheis concluded with a call for members to actively engage in ISMPP activities to further strengthen the community of medical publication professionals.

Keynote: Finding core values in an integrated and sustainable world


KEY TAKEAWAY

  • Andy Pag’s sustainable travel experiments highlight the power of incremental progress and the importance of clear communication in environmental advocacy.

Exploring sustainability: insights from Andy Pag’s adventures

Former BBC journalist and engineer Andy Pag shared his two-decade journey of pioneering sustainable travel. Though often labelled an environmentalist, Pag considers himself an experimenter seeking practical solutions.

Innovative expeditions

Pag’s first major sustainability experiment involved driving from London to Timbuktu in an old Land Rover powered by biodiesel made from waste chocolate. This was considered the first-ever carbon-negative expedition. He later organised the “Grease to Greece” rally, where participants scavenged waste vegetable oil from restaurants to fuel their cars, successfully completing the journey from London to Greece without fossil fuels.

Building on these experiences, Pag set out to travel around the world using sustainable transport. He restored an old school bus and adapted it to run on waste oil, successfully completing the journey while highlighting the potential of alternative fuels.

Lessons in communication

Pag transitioned from experimenter to advocate, emphasising the need for precise messaging. He cautioned that achievements, if not communicated thoughtfully, can be misinterpreted—an insight particularly relevant to medical publication professionals.

The Hero’s journey and scientific method

Pag drew parallels between the hero’s journey—a narrative arc involving a call to adventure, challenges, and transformation—and the scientific method. Both involve exploration, overcoming obstacles, and sharing newfound knowledge.

Trust and incremental progress

Throughout his travels, Pag learned to trust in the kindness of strangers, such as a voluntary military escort in Afghanistan. He advocates for celebrating small advancements in sustainability, recognising that incremental steps collectively lead to significant progress.

Personal choices for reducing carbon footprint

Pag suggests three actions: making sustainable lifestyle choices, supporting policies through voting, and fostering scientific literacy. His experiences serve as a testament to the impact of innovation, communication, and small steps in tackling environmental challenges.

Pag advocates for celebrating small advancements in sustainability, recognising that incremental steps collectively lead to significant progress.

Looking beyond traditional authorship: partnering with patients for inclusion in scientific conferences


KEY TAKEAWAYS

  • The role of the patient at scientific conferences has evolved, from exclusion to tokenism to leadership.
  • Patients are not conference “guests”, but expert partners helping to shape the future.

The time has come to evolve beyond tokenism and acknowledge patients as experts in their own right.

The first plenary session of the day explored the evolution of patient participation in scientific conferences, from exclusion to tokenism to active leadership. One such leader is patient advocate Mercy Shibemba, who shared her experience of growing up with HIV and the associated stigma. She highlighted the principle of “Nothing for us without us”, and underscored that seminal campaigns such as Undetectable = Untransmissible would not have been possible without meaningful patient engagement.

Amanda Boughey (Envision Pharma Group) reflected on the evolution of patient engagement at ISMPP itself, noting the significant progress made since she started working in MedComms 20 years ago. However, challenges remain: results from an interactive quiz during Boughey’s presentation revealed that the biggest perceived barrier to patient involvement at scientific conferences is concerns around compliance.

Enter self-described “compliance nerd” Rina Newton (Code Clarity). Newton clarified some of the misconceptions surrounding patient participation at scientific conferences, for instance, while EU regulations prohibit direct-to-patient drug advertising, this does not preclude patients from attending conferences, where they may:

  • learn about trial findings
  • interact with other attendees
  • engage with medical stands
  • ask questions about medicines
  • speak at symposia
  • give advice on advisory boards.

Simon Stones (Amica Scientific) stressed the need for stakeholders to proactively argue for patient involvement at conferences, citing the European Alliance of Associations for Rheumatology (EULAR) congress as an example of good practice. Specifically, we should:

  • move beyond tokenism—patients should not be viewed as congress “guests”, but as equal partners shaping the future
  • invest in patient leadership
  • build a culture of respect by normalising patient involvement
  • measure impact.

It should be noted that patient-driven impact metrics may differ from conventional measures of success. Shibemba gave the example of a study of youth-friendly health services for people with HIV that failed to achieve its primary outcome (viral suppression), but was considered successful from the participants’ perspective as it demonstrated the importance of integrated health services.

Pascale Cavillon (Ipsen) explained Ipsen’s patient-driven approach starts with the “why”, using early engagement with patients to establish their unmet needs, before collaborating with patient communities to translate science into meaningful solutions. Cavillon highlighted initiatives such as immersive experience training for healthcare professionals to highlight the lived reality of rare disease.

All panellists agreed that the time has come to evolve beyond tokenism and acknowledge patients as experts in their own right.

Sustaining publication quality in a fast-paced world


KEY TAKEAWAY

  • Fast-tracking publications should be reserved for cases of strong justification, and require early, meticulous planning across pharma teams, authors and journals to ensure success.

Expedited publications have become increasingly common, with timelines shrinking from the standard 6 months to as little as 1 month. However, maintaining publication quality requires careful planning, resource allocation, and compliance with Good Publication Practice (GPP) guidelines. During this plenary session, panel members Demetrios Michael (OPEN Health), Karen King (OPEN Health), Sandrine Hardouin (Alexion), Margarita Lens (UCB), Saurabh Gagangras (Novo Nordisk) and Sam Cavana (Taylor and Francis), discussed how to balance speed, quality and compliance when accelerating publication timelines.

Foundation setting

Gagangras likened expedited publications to a dance performance—months of preparation for a precise and rapid execution. Strategic alignment across internal teams is critical. Early engagement with key opinion leaders ensures they are committed to a highly responsive process, while upfront logistical planning—such as completing authorship agreements and pre-submission inquiries—helps avoid delays.

Medical writers should be onboarded early and cover across time zones should be considered. Pre-drafted shell manuscripts and mock figures can allow blinded investigators to review content before database lock. Clear contingency plans for different data outcomes can also help streamline the publication process post-readout.

Compliant author review

Maintaining compliance while expediting timelines requires a structured yet unconventional review process. The panel highlighted the importance of kick-off meetings that clearly define expectations and review timelines, ensuring authors can accommodate shortened deadlines.

The panel also discussed the utility of live review calls to resolve conflicting feedback, and securing calendar dates for these well in advance. Detailed meeting minutes can ensure transparency and compliance while maximising efficiency. Additionally, pre-selecting secondary journal options and understanding the required adaptations in case of rejection helps minimise delays to final publication.

Navigating journal liaison

Cavana provided a publishing perspective on the process. He emphasised that engaging with journals early can smooth the submission and peer review process, but challenges remain, especially in securing reviewers. Cavana advised attendees to consider their use of artificial intelligence (AI) carefully, as well as the adaptability of any potential digital extenders. Journal policies on these aspects can vary widely and might hinder publication or delay the process.

The exception, not the rule

There was unanimous agreement from the panel that expedited publications should remain reserved for cases with strong justification. Examples include areas of unmet needs, Phase III trials supporting regulatory submission, first-in-class drugs, or paradigm-shifting treatments. Fast-track publishing places significant demands on resources and may disrupt ongoing publication plans. Managing stakeholder expectations is also crucial to prevent unrealistic timelines from becoming the norm.

The role of AI

The panel highlighted emerging AI applications could assist the process in the future, and some success has already been demonstrated with plain language summaries (PLS). Other potential uses, such as automated reference management and data validation, are being explored but require further validation to ensure compliance with journal disclosure policies.

Conclusion: need for speed?

 Success in fast-tracking publications involves meticulous preparation, structured review processes, and effective stakeholder communication.

Success in fast-tracking publications involves meticulous preparation, structured review processes, and effective stakeholder communication. While they can accelerate data dissemination, substantial effort is required to balance speed with quality and compliance. It is critical that that these timelines are reserved for rare cases for which there is strong justification.

A discussion on use cases and the adoption of AI within a pharmaceutical, biotech or device company


KEY TAKEAWAY

  • Insights from industry highlight AI’s potential to enhance efficiency, quality and value in MedComms.

James Wright (Bioscript Group) led a discussion on the adoption of AI in MedComms with panel members, Pippa Hadland (AstraZeneca), Tom Grant (UCB) and Swati Krishnan (Boehringer Ingelheim). The aim of the session was to further delegates’ understanding of how to use AI in MedComms, by providing insights from the industry perspective.

AI is all around us, but what is it?

Wright opened the session by explaining what AI is. Simply put, AI allows computers and machines to simulate human learning. Indeed, most of us already use AI in our everyday lives, through navigation systems such as Google Maps, virtual assistants, education, and personalisation of online shopping, social media, and online entertainment.

Generative AI can create original content (text, images, video, audio) in response to users’ prompts. Natural Language Processing brings computer science, AI and linguistics together, “enabling computers to understand, interpret, and generate human language in a meaningful and useful way”.

AI in MedComms: panel insights

Several key themes emerged as the panel shared their experiences of developing and using AI for MedComms:

  • Use cases – examples of AI tools developed and utilised by panel members included predominantly “low security risk” deliverables such as systematic literature reviews, PLS, and a manuscript first draft proof of concept using published secondary clinical data.
  • Efficiency – AI can free-up employees’ time for more strategic tasks while it does the heavy-lifting, eg, summarising large documents, researching new therapy areas, finding details quickly within large quantities of information, or even collating overarching views from 1000s of HCP’s comments in social media.
  • Prompts – Wright emphasised that “we get out what we put in” to generative AI, and well-structured prompts are key. UCB have an app that helps with prompt development, and AI can even be prompted to suggest better prompts!
  • Qualitywhile quality may be a common concern, panel members found comparable quality between AI- and human-generated content.
  • Value – time-saving with AI may allow budgets to go further, meaning better value for money.
  • Data security – maintaining zero risk to patient data, and transparency, are both vital. Security infrastructure around AI is still in its infancy, and represents a challenge, therefore most panel members developed AI tools in-house using closed systems, for “low-risk” projects.
  • Industry/agency collaboration – logistical challenges around transparency and security mean that some panel members have kept AI use in-house, while others have formed successful partnerships with trusted vendors.
  • Training – experience of AI training comprised a mixture of self-learning through experimentation and online resources, and structured learning through company courses.

AI can free-up employees’ time for more strategic tasks while it does the heavy-lifting. In the future it will likely move beyond low-risk projects to include proprietary data and a wider scope of deliverables.

 What does the future hold for AI in MedComms?

With many companies already testing out AI, in the future it will likely move beyond low-risk projects to include proprietary data and a wider scope of deliverables such as infographics or video content. If one thing is clear from this session, it is that AI in MedComms is here to stay.

Roundtable sessions

Attendees then had the opportunity to participate in roundtables, which covered the following topics:

  • Shaping the future of publication metrics
  • GenAI in the real world
  • AI in scientific publishing: overcoming barriers and bridging perspectives across sectors
  • Use of social media in an integrated age
  • Inclusive innovation: building a more accessible future in medical education
  • Improving publication strategies: bridging standard approaches with innovative, proven frameworks
  • Demystifying the submission & guidance for standalone podcast & video articles and extenders
  • Cross-publisher plain language article guidance: have your say
  • What defines a publication as ‘best-in-class’?
  • Strategies for integrated evidence generation throughout product lifecycle: role of the publication professional
  • Unlocking omnichannel success: crafting scientific narratives tailored for audiences and persona
  • Reformat or reform? Evolving manuscript submission processes to put science first
  • Pursuit of parallel publication: potential benefits and current challenges of this growing practice
  • Empowering patients in an integrated age: a multidisciplinary approach
  • The people’s PubMed: empowering patients in the age of misinformation
  • Leveraging AI beyond content creation: creating efficiencies and unlocking possibilities
  • Intellectual property and ethical integrity in the digital age: safeguarding publications through collaboration and innovation
  • ISMPP code of ethics update: sneak peek and discussion

Guided poster tours

Attendees also had the opportunity to attend guided poster tours of the following posters:

  • Analysis of oncologists’ anticipation of and response to clinical data dissemination at ESMO 2023 and ESMO 2024
  • Transforming poster metrics: a low-cost, privacy-preserving solution to measure engagement of posters
  • Establishing a lay review panel to ensure medical research accessibility
  • Practical recommendations for the wider implementation and reporting of sex-specific analyses in medical publications
  • Sins of the father: current medical guidance based on retracted articles in the literature
  • Beyond agreement: how is non-consensus handled in Delphi panels?
  • A survey of the experience, motivations, and added-value of freelance medical writing professionals

Hackathon activity: shaping the future of GPP together!


KEY TAKEAWAY

  • Industry-wide collaboration is essential for refining GPP, focusing on AI integration, patient authorship, real world evidence, and enhancing equity, diversity, and inclusion.

In this interactive session, attendees collaborated in groups to explore gaps in GPP 2022 guidelines and discuss key considerations for future GPP iterations, focusing on 6 key topics:

Advancements in AI

Discussions delved into the anticipated impact of AI on medical publishing by 2026. Key recommendations were to:

  • define the balance between AI and human authorship, with explicit author agreements
  • establish AI disclosure requirements and ethical risk assessments
  • ensure AI compliance with confidentiality standards (open vs closed systems)
  • adapt GPP guidance to keep pace with rapid AI evolution while maintaining professional oversight.

 Defining publication metrics

Participants examined the evolution of publication metrics, questioning whether existing measures effectively capture engagement and impact. The importance of identifying meaningful metrics, highlighting gaps, and ensuring accurate interpretations of publication success were highlighted.

Enhancing patient involvement

The best way to integrate patient involvement within GPP guidance was discussed. Key considerations included:

  • whether to consolidate patient guidance in a dedicated section or distribute it throughout GPP
  • establishing onboarding materials to support patient authors
  • clarifying compensation terms to avoid legal and ethical conflicts
  • ensuring patient involvement is meaningful and adds value to publications.

 Integrating real world evidence (RWE)

Challenges in publishing RWE studies include perception of lower impact, delayed relevance by the time of publication, and complex statistical analyses. Solutions proposed by participants were to:

  • strengthen collaboration between RWE study teams and internal stakeholders
  • incorporate RWE studies in early-stage research planning
  • provide dedicated statistical expertise to ensure robust data analysis.

 Promoting equity, diversity, and inclusion

Discussions underscored the need to embed equity, diversity, and inclusion principles in GPP updates, and recommendations were to:

  • use existing journal lexicons to ensure inclusive terminology
  • advocate for regional representation in steering committees
  • create a congress checklist to evaluate equity, diversity, and inclusion representation in medical meetings
  • hold pharma companies accountable for diverse authorship selection.

 The expanding role of social media

Participants supported broader use of social media but stressed the need for clear, industry-wide guidelines on best practices and regulatory considerations.

Participants supported broader use of social media but stressed the need for clear, industry-wide guidelines on best practices and regulatory considerations.

Eline Hanekamp, co-author of the GPP 2022 guidelines, closed the session by emphasising the growing role of AI, the importance of patient involvement, and the evolution of publication metrics. The insights gathered at the Hackathon activity will be presented to the GPP steering committee for consideration when developing the next iteration of GPP.

Finding the story in data: blending data visualisation, storytelling techniques, and new trends while still upholding core values in medical publications (sponsored and presented by HCG)


KEY TAKEAWAY

  • Effective storytelling and visualisation techniques enhance data comprehension, making complex information more accessible while maintaining scientific integrity and core values.

Tobias Sturt (Add Two Digital) delivered an insightful talk on the role of storytelling and data visualisation in effectively communicating complex information. The session explored how narrative techniques and visual structure can enhance data interpretation, particularly in medical publications, while ensuring adherence to scientific rigour and ethical standards.

The importance of storytelling in data

Sturt emphasised that the volume and complexity of data in the medical and scientific fields are increasing rapidly. Effective storytelling helps cut through this noise, making information more impactful, understandable, and retainable. Visual storytelling is not about manipulating data but about framing it in a way that clarifies meaning while upholding credibility and trust.

Additionally, he noted that while numbers alone present facts, they often fail to engage audiences. A well-structured story provides context, improving relatability and retention of information. This is particularly critical in medical publications, where complex data must be clearly communicated to diverse audiences.

Principles of data storytelling and visualisation

Understanding the audience’s background and expectations is crucial. Data should be structured like a narrative, focusing on key insights to prevent information overload.

Understanding the audience’s background and expectations is crucial. Data should be structured like a narrative, focusing on key insights to prevent information overload. Selection and emphasis ensure that only the most relevant findings are highlighted. While data itself is factual, effective communication evokes emotions that make information more memorable. Using visual structuring techniques such as contrast, positioning, and colour helps guide the viewer’s attention, ensuring clarity and engagement.

Sturt also stressed the need for progressive disclosure—gradually introducing layers of information rather than presenting everything at once. This allows readers to build understanding step by step, making even highly complex data sets more digestible. Balancing simplicity and depth is key to effective storytelling.

The process: find, design, make, refine

Sturt introduced a four-step methodology for data storytelling:

  1. Find – identify the core message within the data.
  2. Design – develop a visual framework to present the story effectively.
  3. Make – create the actual data visualisation.
  4. Refine – test and iterate to improve clarity and impact.

This process ensures that visual storytelling remains purposeful and effective, avoiding the common pitfall of overloading graphics with unnecessary elements that detract from the main message.

Applying visual storytelling in medical publications

Sturt concluded with practical applications for medical and scientific publications, highlighting the importance of maintaining core values such as transparency, accuracy, and ethical responsibility. He discussed ways to ensure clarity in figures and graphs, use infographics to summarise key findings, and adapt storytelling techniques to align with evolving publication formats while preserving scientific rigour.

He also emphasised the role of emerging technologies, such as interactive visualisations and digital platforms, in modern medical publishing. These tools offer new ways to engage readers and convey complex findings dynamically while maintaining the credibility that medical communication demands.

The power of data-driven storytelling

Combining storytelling with data visualisation makes complex medical data clearer and more engaging. Aligning these techniques with ethical standards maintains credibility. As data visualisation evolves, leveraging new storytelling methods while staying true to core values will be essential for enhancing the impact of medical communications.

Want to catch up on events from Day 2 of the meeting? You can read our summaries here.

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Written as part of a Media Partnership between ISMPP and The Publication Plan, by Aspire Scientific, an independent medical writing agency led by experienced editorial team members, and supported by MSc and/or PhD-educated writers.

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[PODCAST] RWE: relevance, reporting, and AI https://thepublicationplan.com/2023/05/25/podcast-rwe-relevance-reporting-and-ai/ https://thepublicationplan.com/2023/05/25/podcast-rwe-relevance-reporting-and-ai/#respond Thu, 25 May 2023 13:14:53 +0000 https://thepublicationplan.com/?p=13924 Real World Evidence (RWE) is the topic of the latest episode of the ISMPP InformED podcast series. Rob Matheis, President and CEO at ISMPP, and Richard White, COO of Oxford PharmaGenesis, discuss how RWE has changed over time and consider the potential impact of artificial intelligence. Subscribe to the podcasts here.

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Meeting report: summary of Day 2 of the 2023 ISMPP European Meeting https://thepublicationplan.com/2023/02/09/meeting-report-summary-of-day-2-of-the-2023-ismpp-european-meeting/ https://thepublicationplan.com/2023/02/09/meeting-report-summary-of-day-2-of-the-2023-ismpp-european-meeting/#respond Thu, 09 Feb 2023 14:37:19 +0000 https://thepublicationplan.com/?p=13158

The 2023 European Meeting of the International Society for Medical Publication Professionals (ISMPP) was held in London on 24–25 January. The first in-person European Meeting since 2020, themed ‘Fueling Creativity’, saw a record 360 delegates in attendance.

A summary of the second day of the meeting is provided below to benefit those who were unable to attend the meeting, and as a timely reminder of the key topics covered for those who did.

A summary of the first day of the meeting can be found here.

Summaries of Day 2

Day 2 opened with parallel sessions, with attendees each having the opportunity to select 2 sessions to attend.

Parallel session: A balancing act: creativity and industry compliance


KEY TAKEAWAY

  • Creative solutions that aim to improve data accessibility, transparency, and patient engagement come with risks, but are achievable with rigorous risk assessment.

In this parallel session, Geraldine Drevon (GSK), Christine Vanderlinden (GSK), Catherine Skobe (Pfizer), Veronica Porkess (UCB), and Jonas Lind Hansen (Novo Nordisk) explored the balance between industry regulations and creativity that must be navigated to address evolving needs for scientific dissemination.

Independent platforms
The first part of the panel discussion focused on scientific dissemination on independent (ie non-industry-sponsored) platforms, such as figshare. Vanderlinden was tasked with identifying risks: lack of control over who can access the data and how the materials are used, the potential for varied quality of data posted on such sites, and how companies should compliantly decide which data are (and are not) uploaded. Despite these risks, Skobe shared a case study demonstrating how Pfizer has successfully developed a process to use figshare to publish manuscript plain language summaries (PLS), ensuring all content is peer reviewed and can be linked to the journal article using a digital object identifier (DOI). After a successful pilot, they plan to expand the process for other uses, such as enhanced publication content, further supplementary information, and eventually as a green open access repository.

Industry-sponsored platforms
The next topic in the session was use of industry-owned platforms. While some risks are similar to those for independent platforms, Porkess discussed further potential issues related to copyright and balancing access versus promotion of data (eg if someone scans a poster QR code, is it appropriate for users to be able to access other posters from that link?). Hansen provided some guidance on these platforms from a legal perspective, advising that the perception of company-owned websites being promotional is false – if content is objective and meets the same criteria as other publications (including in terms of copyright), then such sites are a viable solution for sharing enhanced content, if journals and congresses do not offer the possibility. Hansen emphasised the need to involve legal and compliance teams throughout the process, not just at the end. A case study from Novo Nordisk showed the process of building a freely accessible scientific exchange platform (Science Hub) to address the varied communication preferences of today’s healthcare professionals (HCPs). Novo Nordisk use the platform to house manuscripts or links to manuscripts, publication extenders, congress presentations, and medical education materials, which are all rigorously assessed for compliance before being uploaded.

The perception of company-owned websites being promotional is false – if content is objective and meets the same criteria as other publications…then such sites are a viable solution for sharing enhanced content.

Industry involvement with patients
Finally, the panel discussed the involvement of patients in scientific publications. Vanderlinden explained how to mitigate potential risks associated with patient authors for industry-sponsored manuscripts, including:

  • the importance of careful assessment of why patients should be involved (it may not make sense for every publication)
  • involving patients from the evidence generation step onwards, rather than when considering publication
  • preparing patients to help them provide meaningful feedback on publications.

As raised in the fireside chat session on Day 1, payment of patient authors remains a challenging topic in the industry, with varied processes and policies at different pharmaceutical companies. A final case study from UCB showcased a successful partnership with patients to develop a manuscript on the lived experience with a disease. The protocol was designed in collaboration with a patient council, analysis of key themes was patient-led, and patients were included as authors of both a poster and a peer reviewed manuscript, in accordance with International Committee of Medical Journal Editors (ICMJE) criteria.

The Q&A session following the panel discussion raised some interesting points, including:

  • the importance of developing industry guidelines for digital platforms and partnering with patients, to help improve uptake by risk-adverse companies
  • the concept of a ‘professional patient’ who may work with multiple pharmaceutical companies (and therefore may be considered more objective), but may create challenges for appropriate payment
  • criteria for selecting appropriate publications for patient authorship remain to be defined, with suggestions including active participation in study design, or a topic such as quality of life.

Parallel session: Connecting the dots – turning information into insights


KEY TAKEAWAYS

  • Insights are the combination of information and context, and need to be actionable (aligned with strategic goals) and managed in an ongoing process.

Belinda Dean (3 Stories High) moderated this session, which focused on how insights gathered from external stakeholders can be used to inform strategic planning.

Kicking off the presentations, Sharon Suntag (IQVIA) explained that while information can be gathered from multiple sources, adding context is what provides the insight. Suntag summarised the ‘cycle of insights’:

  • Interrogating data sources: these are unrefined facts.
  • Assessing the information: what is happening?
  • Forming the insights: adding context.
  • Producing an actionable insight: what to do.

Suntag highlighted that strategic goals need to be considered when moving through this process. Suntag also highlighted that data lakes might contain information that is:

  • structured – available in a table format that is defined and searchable and has been developed for a specific purpose
  • unstructured – qualitative data, website content, presentations, medical data such as lab reports, or imaging.

Suntag emphasised that it is important to use the most appropriate data when developing questions to drive insight generation, and that different data sources are needed to ask questions of different key stakeholders.

Laura McGovern (Nucleus Global) then provided an agency perspective on a schematic approach to insights-driven medical planning. McGovern discussed a  project which captured cross-functional insights based on a small data lake. Initially, insights were collated and evaluated against the medical objectives. McGovern highlighted that the quality of different sources needs to be carefully weighed – for example, social media may be fraught with fraudulent posts. Using a digital dashboard can optimise the efficiency of collecting insights at this stage. Once insights were gathered, a cross-functional workshop was held to align on priority actionable insights. A core group then worked to build an action plan (including timeframes and roles and responsibilities). The plan was then implemented, and its success evaluated through the collection of metrics. McGovern noted that the process of insights-driven medical planning is circular, with additional insights gathered and the plan amended as needed.

The final speaker in this session was Clare Baker (Idorsia). Baker shared that the insights-driven medical communications planning process at Idorsia begins with medical objectives and involves alignment of questions and listening priorities across countries and regions. The process was framed as follows:

  • Insight gathering: insights are gathered from medical science liaisons (MSLs) using Customer Relationship Management platforms, medical information requests, and ad boards.
  • Insight analysis: this ongoing process includes manual activities and artificial intelligence (AI) approaches, such as Microsoft Power BI.
  • Insight reporting: at Idorsia, this is manually led by the Medical Operations function to identify insights that can inform product and communications strategies.
  • Insight actioning: determined by cross-functional review.

Baker explained that cross-functional collaboration and sharing feedback are key to the success of insights-driven medical communications planning. Partnerships with agencies can also help with implementing insights within strategic and communications plans.

Cross-functional collaboration and sharing feedback are key to the success of insights-driven medical communications planning.

Parallel session: Publications without borders: harmonising local and global planning


KEY TAKEAWAYS

  • Understanding local needs and priorities will help global publication leads to integrate local publications into the global plan; open communication is key to achieving this.

Maria Haughton (AstraZeneca) chaired this session, and also presented slides on behalf of Michael Sheldon (GSK) who was unable to attend. Tom Grant (UCB) and Anisha Mehra (Ferring Pharmaceuticals) completed the panel, sharing perspectives on challenges and best practices for developing publication plans that integrate global and local priorities. Despite the differences in company sizes, common themes emerged.

The panel all acknowledged the importance of local publications to augment the global plan. Different countries may have different medical priorities and products may have different launch times; local publications can target these specific needs. However, local teams often face resource and time challenges. Small teams are often responsible for multiple products and therapy areas, and often, publications are at the bottom of a very long priority list. Local teams might also be siloed from global, and not aware of processes. High staff turnover at a local level also means that existing knowledge on process is lost, which can translate to challenges for global publications leads, eg last minute requests, ‘surprise’ publications, and the risk of non-compliant publications when processes are not followed.

The panel (and the audience during the Q&A) had some practical recommendations to ensure best practice for local engagement in publication planning. Collaboration was key –a regular call with local teams is a very simple way to keep global informed about local priorities and plans and vice versa. Further, engaging with local teams in a meaningful way is important. This could be through involvement in publication planning workshops. Regular training should be carried out, with the use of case studies to illustrate the benefits of publication planning, as well as the development of clear processes and standard operating procedures (SOPs). The local point of view can also go beyond medical priorities and may impact how publications are delivered – for example, when considering whether local or global agencies should be employed, it is important to consider the preference of the local teams. The recommendations all came back to one core issue: open (and two-way) communication. Engaging with local needs and priorities will help global publication leads integrate local publications into the global plan in a meaningful way, that is beneficial for all.

The recommendations all came back to one core issue: open (and two-way) communication. Engaging with local needs and priorities will help global publication leads integrate local publications into the global plan in a meaningful way, that is beneficial for all.

Parallel session: Guided poster tour

Attendees also had the opportunity to attend a guided poster tour, which visited 4 posters:

  • Accessibility of scientific information for non-English speakers: using browser-based tools to translate plain language summaries (PLS) and abstracts.
  • Ghosts in the machine: retracted articles still haunt the literature.
  • Diversity in medical publications: a cross-sectional evaluation of COVID-19 vaccine research.
  • Evaluating the publication of randomised controlled trials in inflammatory bowel disease by trial outcome and journal attributes.

Once upon a time… Effective storytelling in an age of omnichannel communication


KEY TAKEAWAY

  • Providing a clear, succinct, and aligned narrative using a variety of formats, across different channels and to a broad, cross-functional audience requires advanced planning but is a vital component of effective scientific storytelling.

Chaired by Caroline Halford (Springer Healthcare), the ever-growing role of omnichannel communication for effective storytelling was discussed in this plenary session. Despite great changes in communication methods over the past 20 years, succinct and engaging content that maintains scientific integrity continues to underpin effective communication across multiple types of media. Omnichannel communication is a vital component of this: a holistic method to share preferred content in preferred formats, that takes into account the readers’ perspective and delivers what they want to read.

The new normal: bitesize information needs

Nathalie van Havre (European Hematology Association) kicked off the session with a staggering statistic: since 1950, medical knowledge doubling time has decreased from 50 years to just 73 days. Efficient communication needs to adapt, harnessing different methods of learning.

Van Havre noted that microlearning is a simple and cost-effective addition to an educational strategy. Delivering scientifically sound information in a variety of formats, microlearning keeps learner fatigue at bay. At EHA, microlearning is used to deliver key topics of interest to an audience that spans 100 countries, through initiatives such as ‘Learning Mondays’, ‘Thinking Thursday’, and more in-depth case studies. Describing some key elements of a successful microlearning piece, van Havre highlighted the importance of interactivity, linking out to relevant sources, using a mixture of words and pictures, and encouraging a transferable, systematic thinking process.

Creative storytelling across communications

Fiona Thomas (KPMG) explained that storytelling doesn’t just happen at a single point in time. A great story is one that is retold over and over, and stories must align, complement, and build on one another across the various formats of communication. In scientific storytelling, a clear and aligned narrative needs advance planning and must be developed with a broad audience in mind.

Thomas also noted that a scientific story should be complete regardless of the journey the consumer has taken. She shared some key takeaways:

  • Content and clarity are key.
  • Profile your learners, not HCP type.
  • Scientific storytelling is a relay: build the story and plan for the unexpected.

In scientific storytelling, a clear and aligned narrative needs advance planning and must be developed with a broad audience in mind.

Getting attention in the digital age

In the final presentation of the session, James Dathan (AstraZeneca) challenged the standardised processes in scientific storytelling. Using posters as an example, the format of scientific communication has changed little, despite user feedback showing a clear preference for infographic presentation of data. The use of omnichannel communication, including QR codes, allows readers to choose whether to delve more deeply, and even virtually connect with presenting authors, allowing posters to highlight the main results and conclusions. Dathan noted that in an age of digital adoption, front and centre information is no longer necessary, and innovation should be the motivator for change. Concluding, Dathan underscored the need for collaborative co-creation of scientific stories that embrace omnichannel communication.

The Q&A session also raised some interesting points:

  • Collaborative co-creation of digital content is key to managing risk and understanding how to use social media compliantly.
  • While we need to consider the different time zones of our audience, the latest data suggest Tuesday and Thursday mornings are good for sharing digital content. Releasing the same type of content on the same day provides consistency.
  • Catering for different learning or HCP types isn’t sophisticated enough. We need to combine different formats and modalities to support different learning styles, while also considering different demographics and digital competence.

Member research oral presentations

AI for the development of clinical trial lay summaries: are we ready to replace writers with machines?


KEY TAKEAWAY

  • Improvements are needed before AI can take over from writers in developing clinical trial lay summaries.

In the first of the three presentations in this session, David McMinn (Lay Summaries Ltd) shared findings from research into whether automatic text summarisation using natural language processing can accurately generate lay summaries. A literature search was performed to identify existing AI models, which were performance tested. The two best performing models were then fine-tuned and re-tested. McMinn found that the selected models were able to accurately produce certain sections of the lay summary, namely the title, background information, objective, and generic content but struggled with the results, adverse events, flow, and complex trial designs. The performance of AI models may be improved in the future with more powerful computers, larger data sets, enhanced metrics, and targeted text extraction. McMinn concluded that while AI does show promise, improvements are needed before writers can be replaced by machines.

Are conference presentations accessible? Insights from an online survey to improve equity


KEY TAKEAWAY

  • Less visual clutter on posters and providing slides ahead of talks would improve the accessibility of conference presentations.

James Wells (CMC Connect) presented results from a 23-question online survey, which was designed to establish accessibility requirements and preferred methods of receiving information among conference attendees with diverse needs. Of 493 respondents, 57% reported at least one accessibility need or disability, most frequently processing, sensory, hearing, or visual needs. Respondents preferred posters with less text, considering it easier to gain information from the #BetterPoster design than infographic examples or traditional text-heavy posters. When asked how posters could be improved, recommendations included:

  • less visual clutter (71%)
  • bigger text (48%)
  • bigger figures (43%)
  • plain language (42%)
  • audio summary via a QR code (32%).

Respondents felt it was easiest to gain information from talks with traditionally formatted slides containing text (with or without images), compared with TED-style talks with limited slides, slides with little text, or panel discussions with no slides. Recommendations to improve the accessibility of talks included:

  • providing slides ahead of the talk (66%)
  • recording a video of the talk for attendees to watch afterwards (60%)
  • more verbal explanations of images (50%)
  • bigger images (48%)
  • less text on slides (45%)
  • live closed captions (34%).

Respondents also provided recommendations for conference spaces, which included ensuring that there is sufficient seating (including in poster halls), ensuring sufficient space for wheelchair access, providing quiet spaces, improving acoustics/microphone use, and providing quality virtual options.

Respondents felt it was easiest to gain information from talks with traditionally formatted slides containing text (with or without images)…Recommendations to improve the accessibility of talks included providing slides ahead of the talk.

Adverse event reporting in industry sponsored primary clinical trial articles


KEY TAKEAWAY

  • A substantial proportion of industry-sponsored clinical trials articles use vague, general phrases to report adverse events.

In the final presentation of the session, Susan Wieting (Takeda) discussed the results of a study performed to assess how well the recommendation from Medical Publishing Insights and Practices (MPIP) to avoid overly general descriptions of adverse events (AEs) is followed in industry-sponsored clinical trial publications. A MEDLINE search was performed to identify abstracts of industry-sponsored peer reviewed articles (from the top 10 pharmaceutical companies by 2021 revenue) published in 2016–2022, that included one of the following phrases:

  • safe and well tolerated
  • AEs seen were minor and generally well tolerated
  • no unexpected AE
  • or a similar phrase.

In total, 103 articles were identified: 13 articles contained the phrase “safe and well tolerated” and 92 contained a similar phrase to those specified. Of these 92 articles, 49 used the phrase “well tolerated” and 24 included “generally well tolerated”. When assessed by year, the use of vague phrases had not reduced over time. Wieting noted that vague phrases are not informative, and highlighted the opportunity for the industry to consistently report specific AEs, which would increase the clarity and robustness of data.

Keynote: Global economic and policy influences on the pharmaceutical industry


KEY TAKEAWAY

  • Low–middle income countries are leading the way in healthcare innovations for an ageing population.

The Day 2 keynote presentation was given by Mark Chataway (Hyderus/Baird’s Communicant Management Consultants Ltd), who laid out the extent of the global challenges facing healthcare and what these might mean for medical communications.

An ageing global population

Chataway set the scene by charting the enormous changes in life expectancy seen over the last decade and forecast over the years ahead. In short, the world is getting older. Chataway outlined that life expectancy is generally higher in countries with greater levels of healthcare spending. He made the case that the additional cost can be offset to some degree by the spending patterns of older people, who will spend money rather than save it, thus giving back to the economy. This is augmented even further if ‘retired’ people also work part time, although Chataway noted that retirement ages haven’t yet kept pace with increased life expectancy.

What does this mean for medical communications?

  • Even more attention to measures such as quality-adjusted life years and disability-adjusted life years
  • increased focus on productivity gains and health-care resource utilisation associated with treatments
  • a need for better patient education on the quality of life possible in older age.

Health spending and system innovations

Another global trend Chataway highlighted was the decrease in extreme poverty. Despite this, health spending in low–middle income countries has not kept pace with increases in life expectancy. There are signs this is starting to change, as health sovereignty becomes more important in some regions and emerging economies look to invest in health technology. Examples include:

  • the G20’s focus on digital health innovations and solutions
  • the increased prevalence of innovative healthcare networks in some middle-income countries (eg in South Africa, nurse-led clinics refer through to leading institutions)
  • innovations capitalising on efficiencies of scale, as previously reported for heart surgery in India.

What does this mean for medical communications?

  • Some medical specialties are changing or even disappearing.
  • Publication professionals will need to support HCPs and researchers who are new to publishing.

As health sovereignty becomes more important in some regions and emerging economies look to invest in health technology…publication professionals will need to support HCPs and researchers who are new to publishing.

Personalised medicine

Chataway closed by noting the expansion of personalised medicine and related infrastructure, such as the large national health records database currently being established in India.

What does this mean for medical communications?

  • Registries and databases will become accessible to researchers in areas where cost may have been prohibitive until now.
  • Conversely, some of the largest new databases may place restrictions on what can be published.

GPP and me


KEY TAKEAWAY

  • GPP 2022 serves as expanded guidance to medical publications professionals and continues to evolve, yet authorship remains contentious and questions remain around the use of social media and AI.

The final panel discussion session looked at how GPP 2022, published in August 2022, has changed working practices for medical publications professionals. Moderated by Eleanor Raynsford (Ipsen), panellists were Laura Dormer (Becaris Publishing), Eline Hanekamp (Excerpta Medica), Fiona Plunkett (Articulate Science), and Vanderlinden. All panellists were GPP 2022 steering committee members and authors.

Ahead of the meeting, a questionnaire circulated via the ISMPP community forum and LinkedIn received 29 responses, with 59% reporting that the updates to GPP had affected their day-to-day activities. 75% of respondents still had questions about GPP 2022, aligning with three main topics: authorship, reimbursement, and patient involvement. These topics formed the basis of the panel discussion. The panel noted that the survey results were as expected, stating that “GPP 2022 is not a revolution.  It is an evolution, providing supplementary material to give everyday guidance.”

Authorship

GPP 2022 expanded guidance on authorship in line with ICMJE recommendations, including removing limits on the number of authors. The panel discussed that authorship should be considered on a case-by-case basis, and not subject to arbitrary limits. The panel noted that a steering committee should be established well in advance of publication initiation. The steering committee is then best placed to discuss any queries and concerns arising during publication development.

Authorship should be considered on a case-by-case basis, and not subject to arbitrary limits…The ISMPP Authorship Algorithm tool can help to determine author contributions to ICMJE criteria #1.

The ISMPP Authorship Algorithm tool can help to determine author contributions to ICMJE criteria #1 (substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work). Where large numbers of potential authors are involved, it is unlikely that all can contribute substantially to publication development. Assigning a study or working group would capture all individuals involved – these contributions are also indexed, for example on PubMed. Where appropriate, contributions should also be acknowledged and captured on indexing sites. The panel also discussed the case of individuals becoming unavailable during publication development, eg through parental leave or a new job. In this case, their role as author must be reassessed using the ICMJE criteria. A discussion should be held in advance of any known leave (ideally with the steering committee) on whether the individual will be able to fulfil their role. Sensitivities should be considered for leavers, for example those moving to competitors. Acknowledgement or contributorship may be suitable alternatives.

A case study was shared by Helen Chambers (Costello Medical), who noted that GPP 2022 had helped enforce good practice when discussing publication development processes with clients. Key to this was the guidance that all authors should be engaged prior to project initiation. Chambers reflected that ultimately, early author input drives a smoother process.

Reimbursement

GPP 2022 provides further details for reimbursement of HCPs and patients, the latter being a hot topic of discussion in other sessions. The panel noted that it is transparent, legitimate, and appropriate that a provider of services or a patient should receive payment for their contribution and still qualify as an author, as long as a full disclosure is incorporated. While authors cannot be paid for their name being listed as an author, it is possible to reimburse their time for contributing their expertise: patients should not be excluded as authors for receiving reimbursement for their services. However, company reimbursement policies for patient authors vary.

Tamzin Gristwood (Oxford Pharmagenesis) shared a case study where GPP 2022 provided clearer rationale around naming medical writers on review articles. Gristwood noted that if appropriate, the writer can be an author and also receive payment (through their professional medical writing role) in terms of time spent developing the article.

It is possible to reimburse [patient’s] time for contributing their expertise: patients should not be excluded as authors for receiving reimbursement for their services.

Patient involvement

GPP 2022 also provided guidance on working with patients, to ensure patient expertise is respected and assistance provided (if required) to help them reach their full potential for contributing as an author. GPP 2022 has increased the confidence of both agencies and pharmaceutical companies working with patients, providing guidance on how best to involve patients in the publications process. Importantly, patient author involvement must be meaningful and valid rather than a tick-box exercise, with early engagement ensuring that patient authors can be involved throughout the publication process. Patient authors and patient reviewer feedback are both invaluable, and provide a different perspective from that of HCPs.

Outstanding queries

Several areas of outstanding queries were also raised during the session.

In terms of patient involvement:

  • Although the development of PLS is becoming more common, is this medium providing patients with a voice if their involvement is limited?
  • Should journals question a lack of patient authors, and should they be looking to update their guidance on authorship?
  • Authors are generally required to provide details such as qualification, affiliation, and contact details. While a ‘traditional’ author can provide their work credentials, there is no clear guidance for patient authors.

In terms of social media:

  • There is clearly a need for guidance on social media, but GPP is not best placed to provide that guidance. Guidance would be best coming from a legislator or regulator.
  • Should authors work with publishers, so that journals share publications on social media?

In terms of AI:

  • While no information about the role of AI in publications was given in GPP, it was noted that the World Association of Medical Editors (WAME) and Nature both recently shared information that may serve as a useful reference point.

Poster awards, exhibitor raffles, and closing remarks

Rob Matheis (ISMPP President & CEO) and Raynsford closed proceedings, thanking the abstract review committee and poster presenters. This year’s poster prize winners were congratulated:

  • Most reflective of meeting theme: Why did it go viral? An informatics-based case study of exaggerated language in news and social media – Hollie Rawlings, Tomas Rees, Lubaina Koti, Avishek Pal, and Andrew Liew.
  • Best original research: Does publishing on medRxiv affect a manuscript’s outreach? – Pedro Caldas Custodio de Campos Silva, Christian Matheou, Alex Marshall, and Shilpa Khobragad.
  • Most innovative digital poster format or enhancement: Ghosts in the machine: retracted articles still haunt the literature – Stephen Craig and Andy Shepherd.

Why not also read our summary of Day 1 of the meeting?

The Publication Plan also looks forward to bringing you more insightful and thought-provoking coverage from the forthcoming 19th Annual Meeting of ISMPP, due to take place on 24–26 April 2023 in Washington, DC.

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Written as part of a Media Partnership between ISMPP and The Publication Plan by Aspire Scientific, an independent medical writing agency led by experienced editorial team members and supported by MSc- and/or PhD-educated writers.

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Meeting report: summary of Day 1 of the 2023 ISMPP European Meeting https://thepublicationplan.com/2023/02/07/meeting-report-summary-of-day-1-of-the-2023-ismpp-european-meeting/ https://thepublicationplan.com/2023/02/07/meeting-report-summary-of-day-1-of-the-2023-ismpp-european-meeting/#respond Tue, 07 Feb 2023 14:13:23 +0000 https://thepublicationplan.com/?p=13127

The 2023 European Meeting of the International Society for Medical Publication Professionals (ISMPP) was held in London on 24–25 January. The first in-person European Meeting since 2020, themed ‘Fueling Creativity’, saw a record 360 delegates in attendance.

A summary of the first day of the meeting is provided below to benefit those who were unable to attend the meeting, and as a timely reminder of the key topics covered for those who did.

A summary of the second day of the meeting can be found here.

Summaries of Day 1

Chair’s Welcome & ISMPP Presidential Address


KEY TAKEAWAY

  • ISMPP membership and the number of CMPP™ certification holders is growing; members of our profession should embrace creative approaches to help ensure that scientific messages reach stakeholders such as time-poor HCPs.

Rob Pilbrow (Chair of the ISMPP European Programme Committee; Syneos Health Communications) opened the meeting by welcoming attendees, thanking ISMPP and the meeting sponsors and exhibitors, and noting the donation made to the Science Art Writing Trust on behalf of the meeting faculty. Pilbrow emphasised the record-breaking number of meeting delegates, abstract submissions, and poster presentations this year. Introducing the meeting theme, Pilbrow highlighted the value of creative approaches in our industry, and noted that the meeting would explore the science of creativity and how to implement creative approaches to reach novel solutions.

Next up, Ann Gordon (Secretary of the ISMPP Certification Board; CMC Affinity) gave an update on the Certified Medical Publication Professional™ (CMPP™) programme. Gordon highlighted the growing number of CMPPs, exceeding 1,570 following certifications in March 2022. CMPPs are now represented across 4 continents, and individuals from several new countries gained certification in 2022. Gordon reviewed recent and upcoming changes to the CMPP™ programme, with the new 5-year certification cycle (for those certifying from 2022), an updated exam blueprint, and expansion of the valued CMPP™ Mentor Programme.

Rob Matheis (ISMPP President and CEO) then gave the leadership update. Matheis emphasised the importance of medical publication professionals, noting that publications underpin many pharmaceutical company operations, but also increasingly reach external stakeholders directly (such as healthcare professionals [HCPs], patients, caregivers, and payers). While over time, the focus has shifted from publication quantity to impact, the foundation of the profession has remained the same – albeit with an unprecedented need for ethical, credible, and timely scientific communication. Medical publication professionals are now not only responsible for peer reviewed publications, but must implement other approaches to effectively deliver medical information to stakeholders such as time-poor HCPs. Looking to the meeting theme, Matheis noted that meeting these information needs means that we need to be creative, capturing attention to ensure that scientific messages are seen and read by intended audiences. Matheis shared some examples of how attendees could induce a creative mood state, such as through listening to music or movement, and highlighted how one creative success can lead to another. In closing, Matheis noted that ISMPP was thriving, with a steadily growing membership, and reflected on key successes in 2022, including the roll-out of the ISMPP Authorship Algorithm. In 2023, ISMPP will continue to focus on innovations in the industry, while helping to ensure that new members of the profession and smaller companies are equipped with the tools they need to deliver ethical, credible, and effective medical communications.

Fireside chat: Blazing a trail to successful patient partnerships in publications


KEY TAKEAWAYS

  • Patient partners can add value throughout the publication process.
  • Establishing criteria, tools, checklists and templates may be helpful for the development of PLS.

In this session, moderator Dawn Lobban (Envision the Patient) and speakers representing patients (Trishna Bharadia [The Spark Global]) and the pharmaceutical industry (Catherine Skobe [Pfizer], Jamie Griffin [BMS] and Avishek Pal [Novartis]) explored three ways of partnering with patients in publications:

  1. Involving patients in the planning of publications.
  2. Working with patients as co-authors.
  3. Incorporating plain language summaries (PLS) into publications.

Skobe described Pfizer’s Patient Collaborative Board, which was set up with the mission of actively engaging patients throughout the publication process, and with the purpose of ensuring patients are collaborators and partners. Important issues that were considered during the formation of the board included expanding demographic diversity and geographic reach, creating a ‘terms of requirement’ charter, and paying patients fair market value for their involvement. Notable achievements of the board to date include involvement in voicing the case for open access at Pfizer; and the development of a 3-year plan for the board.

Recognising that resource limitations might preclude smaller pharma companies from being able to emulate Pfizer’s undertaking, Skobe provided some smaller scale suggestions:

  • Listen to patients to understand their needs.
  • Involve at least 1 patient to advise on the development of processes for working with patients.
  • Share the view of patient advocates across the organisation: it is much more meaningful to hear from patients directly than indirectly via company members.

Next up, Bharadia began by making recommendations related to the practical aspects of involving patients in publications. “Be open to all the different ways that patients can be involved” was her first recommendation, which was well illustrated by the multitude of roles that Bharadia has held in the patient engagement arena. Secondly, Bharadia advised thinking about who you’re involving: while the patient voice includes caregivers, family members, and patient group representatives, only patients have direct lived experience of their condition. Thirdly, appreciate that not all patients are the same in terms of their skills, expertise, knowledge, and experience: their suitability for and needs for support with involvement in publications vary accordingly.

While the patient voice includes caregivers, family members, and patient group representatives, only patients have direct lived experience of their condition.

Bharadia went on to highlight ways in which patients meet International Committee of Medical Journal Editors (ICMJE) authorship criteria, and also provided the following recommendations to facilitate their authorship:

  • Patients can meet criterion 1 by helping to design studies that are patient-centred, with relevant patient-reported outcomes and quality-of-life measures.
  • Patients can meet criterion 2 by ensuring that the work identifies and prioritises aspects of their condition that are relevant and important to patients, and that the work is easy for patients to understand.
  • In order to meet criterion 3, patients should be allowed sufficient time to review the whole publication.
  • With respect to criterion 4, patients should recognise that they don’t need to be an expert in every area, but they should trust the contributions of their co-authors and have a good understanding of the peer review process.

Bharadia concluded with invaluable insights into working optimally with patients on publications:

  • Maintain flexibility in terms of the timing and frequency of meetings, the required format of comments and by allowing offline and online review.
  • Create the right environment for patients so they feel comfortable to speak up, without feeling judged.
  • Direct patients to helpful resources, eg Workgroup of European Cancer Patient Advocacy Networks (WECAN), Envision the Patient.
  • Remember that agreements aren’t one-way; patients should be empowered to ask for changes.
  • Make opportunities for partnerships equitable by providing compensation for time spent working on and presenting research.

In the final part of this session, Griffin described how BMS has implemented PLS across their publications, with the ultimate aim of improving patient care. Formerly, no clear policy existed at BMS with regards to PLS: they were developed only where the journal allowed or required a PLS; there was variable expertise in the agencies involved in writing PLS; and there was variability in the budgets for PLS. Now, BMS have clearly defined criteria around the development of PLS, which state that they should:

  • be developed following prospective identification in the publication plan
  • be open access
  • provide a summary of a single publication
  • accompany the original manuscript (where feasible).

The criteria have built-in flexibility, allowing the development of PLS for other publications where journals or congresses allow or require one.

Legal and Compliance may push back on the development of PLS, prompted by concerns that they constitute direct advertising to patients. Defining the broad audience for PLS, which extends beyond patients, can help to achieve buy-in, Griffin noted.

Audiences for PLS include:

  • time-poor specialists/generalists
  • payors/policy makers
  • HCPs with English as a second language
  • allied HCPs
  • lay audience (including patients and carers).

BMS has developed a comprehensive implementation pack consisting of tools, checklists, and templates, which has been a big help for publication leads and reviewers. Finally, the formation of expert patient panels to review PLS has been “immensely useful”, culminating in the development of the following list of elements that PLS should include:

  • explanation of patient demographics
  • infographics
  • a link to the original article
  • section headings to break up the text
  • anticipated side effects
  • phonetic spelling of drug names
  • empathetic tone/content
  • links to additional resources and details for patients who want to explore the topic further.

Keynote: Effective creative thinking for success


KEY TAKEAWAYS

  • Embracing creativity in medical publications should enhance their impact.
  • New ideas frequently emerge from combinations of existing thoughts.
  • Creativity can be practiced to build on and improve our innate abilities.

Duncan Stevens (creativity consultant and founder of The Influence Association), set out to demonstrate the importance of creative strategies in the field of medical publications and the wider medical communications sphere. He opened his presentation by asserting that while ideas are important, it is also crucial to be able to persuade others to act on those ideas.

The importance of creativity

Stevens outlined several ways in which creativity can be useful in medical publications:

  • to bridge the gap between traditional publications and medical communications
  • to create impact beyond the mundane
  • to allow our communications to cut through the noise, inspiring readers to take action
  • to promote growth and innovation.

Stevens emphasised that creativity is innate in all people, but that to embrace it fully, we must train and develop our creativity like a muscle. One way to do this is by building fun into our daily routines, with playful behaviour often allowing more creative thoughts to emerge.

Creativity springs from a combination of curiosity, enthusiasm and courage.

Ideas arise from other ideas

Stevens highlighted that the best ideas often build on other existing ideas. When brainstorming, we should change our approach, aligning ourselves with the original meaning of the word Abracadabra – “I will create as I speak”. It is important to try to gather as many ideas as possible as quickly as possible. In this way, we can start to ‘stack’ the ideas to build something that is greater than the sum of its parts.

Successful idea creation and development requires several different phases:

  • Preparation: firstly, we must gather information on what we want to change, asking ourselves what the problem is and what is wrong with our current solutions. This should ideally involve collaboration with others both inside and outside our own organisation to increase the breadth of understanding.
  • Incubation: once we are armed with understanding, we can pause to let our subconscious take over. Ideas often emerge when we are partially focused on another activity, such as showering or running. Success can be increased by incubating insights in multiple minds at the same time – eg, across a team.
  • Illumination: otherwise known as the “Eureka!” or “Aha!” moment, where the solution to the problem suddenly appears in the forefront of our minds.
  • Evaluation: once an idea is formed, it is necessary to interrogate it to consider its value as a solution to the initial problem.
  • Verification: the final stage in the process, where the idea is released and tested by a wider community.

Every failure is a step in the pathway to eventual success.

Finding time for creativity

Stevens asserted that the most significant obstacle to creativity (or at least the most cited) is a lack of time. He suggested that we can increase our creative time by modifying our meeting plans – shortening meetings to ensure adequate focus and inviting only those who are necessary to the objectives. In addition, we should apply the POST principle to maximise the efficiency of meetings, ensuring that each calendar entry has a purpose, objective, structure, and timeframe.

Stevens concluded with the thought that as humans we are all the same, but also different. Creativity in its essence is perception: by changing the way we perceive the world, we can also increase our creative powers.

Roundtable sessions

Attendees then had the opportunity to participate in roundtables, which covered the following topics:

  • Enhanced content: what, when and how?
  • Applying artificial intelligence (AI) and analytics to unstructured scientific content to discover new data and drive value
  • Creating consistent communication through effective scientific communication platform socialisation
  • Diversity, equity & inclusion in medical research and publishing: what does it look like?
  • GPP: fueling the fire of PLS
  • How can we foster publications on patient engagement initiatives? A multistakeholder perspective
  • Clear and present data: how to increase the impact and reach of your medical publications with data visualisation
  • Much ado about access
  • Copyright and licensing dos and don’ts
  • Innovating to improve sustainability in medical communications
  • The art of incorporating the patient voice for inclusive medical communications
  • How AI can increase accessibility and compliance of medical publications: generating PLS
  • The driving force of creativity in publications.

The publication professional’s guide to trends and challenges in evidence generation


KEY TAKEAWAYS

  • Utilising RWE and understanding the patient voice is challenging but important for patient-centric healthcare.
  • Publication plans should incorporate RWE in efficient and smart ways, utilising technologies in a safe and ethical manner.
  • New sources should be considered to gather valuable insights and the patient voice should be incorporated from the outset.

The RWE explosion: benefits and challenges

Sreeram Ramagopalan (Industry Representative in Access Evidence) kick-started this session, noting that the publication of real world evidence (RWE) studies on PubMed has increased from 10 articles in 2009 to 3,000 in 2021. Ramagopalan highlighted that randomised controlled trials (RCTs), the gold standard for benefit-risk assessment of a treatment, have inherent disadvantages given the controlled environment with strict patient population criteria that aren’t always reflective of the disease population or clinical setting. Therefore, RWE is valuable and important in addressing questions that cannot be answered by RCTs, essentially filling information gaps needed to improve healthcare and inform guidelines and policies.  Questions that might be addressed through RWE include:

  • Is there an unmet need?
  • How are drugs being used in the real world?
  • What are the prescribing and ultilisation patterns?
  • What are the safety concerns in a real-world setting?
  • How does the effectiveness of a drug compare with others in a particular therapy area?
  • What are the benefits to patients, including a deep dive into patient-meaningful outcomes?

RWE is valuable and important in addressing questions that cannot be answered by RCTs, essentially filling information gaps needed to improve healthcare and inform guidelines and policies.

Ramagopalan noted that regulatory bodies such as the FDA and Health Technology Assessment agencies actively seeking or mandating RWE inclusion in regulatory submissions has resulted in a drive towards RWE studies. Ramagopalan highlighted the importance of publications in showcasing the validity of data, as well as the robustness of methodology, so that assessment bodies can confidently make decisions based on the RWE provided to them.

Understanding the patient experience: what, why, and how

The next speaker was Alex Morton (MEDiSTRAVA) who gave the audience a whistlestop tour of what patient experience means, why it is important, and how to go about collating insightful information. Morton noted that patient experience could include the following aspects:

  • What are the signs and symptoms experienced by patients and how do these impact quality of life?
  • Do symptoms change over time and how do patients feel about this?
  • What are patients’ expectations from current as well as potential treatments?
  • How does a patient’s view impact their treatment and disease outcomes?
  • How has treatment burden influenced overall patient experience?
  • For trial participants, what is the burden of participating in clinical trials?

The patient experience must be exploratory in nature rather than validating one’s own assumptions, and the patient voice must be incorporated as early as possible, as opposed to fulfilling a box-ticking exercise.

Gathering information on the patient experience must be exploratory in nature rather than validating one’s own assumptions, and the patient voice must be incorporated as early as possible, as opposed to fulfilling a box-ticking exercise. Morton also highlighted that diversity and inclusion are important when gathering patient insights. Factors such as patient knowledge, skills, and confidence are all factors that will affect views and experiences and should be borne in mind when designing methods or approaching patients. Patient insights should be gathered in a variety of ways, including using qualitative and quantitative methods, and digital/virtual and face-to-face formats. Leveraging social media and AI could reveal key areas of unmet need and inform strategies and publication planning.

The discussion then shifted to the importance of collaborating with patient advisory groups as well as caregivers to gain key insights. However, this is not an easy task:

  • Establishing relationships with advocacy groups and identifying the right patient partners is time-consuming.
  • Scepticism about the pharma industry is a barrier to building mutual trust.
  • Requests to participate can be overwhelming, given huge ‘competition’ for patient involvement in many disease areas.
  • It can be challenging to engage with some hard-to-reach patient groups to gain diverse, inclusive perspectives.

Nevertheless, incorporating the patient voice from the very early stages of a clinical study is important and beneficial to the study quality.

Evidence emerging from innovative technologies

The final speaker of the session, Tove Holm-Larsen (Silvi/Ghent Universitet) discussed how innovative technologies can help to close the gap between clinical trial efficacy and real  world effectiveness.

Holm-Larsen strives to optimise evidence-based medicine using Big Data and AI. Along with her collaborators, Holm-Larsen founded the “Evidensbaseret Medicin 2.0” group, which comprises 3 scientific projects: HedaX, OSCAR and Silvi.ai.

  • HedaX aimed to develop a digital platform to collect and exchange health data securely and ethically from various sources (eg government databases, social security registries, and real world data collected from patients using apps and wearables) to enable combined information to inform personalised healthcare. Holm-Larsen noted that 2 ongoing pilot projects in cancer and bipolar disorder are at finalisation stages.
  • OSCAR is intended to be a one-stop shop for clinical research, where one could “buy a data analysis”, helping to implement modern data-driven healthcare.
  • The goal of ai is to speed up the collection and analysis of published data to enable efficient creation of systematic reviews and meta-analyses.

Is a picture worth a thousand words? Using creative approaches to address literacy and accessibility of scientific information: a patient perspective


KEY TAKEAWAY

  • Co-creation of scientific materials with patients is the key to accessible and useful resources for lay audiences.

This session, moderated by Susan Daniels (Lumanity), was derived from a member proposal and explored patient perspectives on how creative approaches can address the challenges of developing scientific materials for lay audiences.

Sharing scientific information with the public and the patients: the need and the challenge

Jan Geissler (Patvocates) opened the session by emphasising the information gap for lay audiences and the huge demand from patient communities to understand the science behind their diseases, available treatments, and ongoing clinical trials. He added that the information gap is especially wide for patients with rare diseases, where lack of information and late or incorrect diagnoses can increase stigma and information inequity.

Health literacy is the ability of individuals to access, understand, and use health information to support their own (or their loved ones’) health, and in people with cancer it has been correlated with care experiences and quality of life. However, Geissler presented findings that almost half of respondents in a European survey had limited or inadequate health literacy. Traditional peer reviewed scientific publications are comprehensive and accurate sources of medical information, but medical communications professionals need to ensure that scientific content is accessible and has a clear message for lay audiences.

“Scientific publications offer a valuable source of information…but only if people are able to find, view and understand them.” – Jan Geissler

Geissler closed by emphasising that time to access information is a key concern for patients and that working with patients from an early stage will help ensure effective information dissemination.

Engaging patients in the process: does the audience know best?

Graeme Johnston (Patient Focused Medicines Development) continued by discussing the needs of lay audiences from his perspective as a patient, and echoed Geissler’s sentiment that it was uplifting to see this topic as a focus of the meeting. He emphasised that while patients may not know ‘best’, their unique perspectives and lived experiences are vital and should be captured through co-creation of scientific materials. He noted that lay medical communications should:

  • be clear, interesting, and accessible
  • give the reader the ability to delve deeper
  • be from a reputable source
  • include striking visuals, and be attention grabbing.

Using a PLS example, Johnston demonstrated how to co-create. The process starts with selecting the correct patients to involve based on their experience and language skills. Roles and responsibilities should be clearly stated upfront and co-creation should be continued throughout the development process, with special consideration regarding the clarity of briefs and accessibility of documents. A two-way feedback process is key to allow patients to see how their input is used. Finally, Johnston reminded everyone to appropriately acknowledge patient contributors and remember to share the approved version with them.

 

“We need to be more creative in how we approach discussions with patients to create resources that are of use.” – Graeme Johnston

Johnston referred to free resources on engaging patents in medical publications, including an open access course from WECAN, and the Patient Engagement Management Suite, which provide good practice guides, toolkits, training materials, and how-to-guides.

Using creativity to improve accessibility of scientific information

Richard Lee (Lumanity) echoed the meeting theme with his insights on creative solutions to generate accessible scientific information. He defined creativity as the ability to be different in a useful way, and reminded the audience to ensure this utility is not forgotten when developing lay materials.

Lee echoed Johnston’s point on the importance of getting feedback from the end user throughout the process, and provided examples of how to address potential accessibility barriers for patients:

  • Visual (eg, colour blindness) – use a contrast checker to ensure all elements are clearly visible; provide screen readers as per Web Content Accessibility Guidelines.
  • Motor/mobility (eg, motor impairment, arthritis) – make sure users do not have to scroll too much to view the information they need.
  • Auditory (eg, hearing difficulties) – use captions on presentations and provide transcripts.
  • Cognitive (eg, dyslexia, sleep deprivation) – use columns, subheading, and icons as visual aids, with large font sizes; avoid justified text.

Daniels summarised this session by encouraging attendees to “find their fuel” when developing medical communications:

  • Find your audience.
  • Understand their needs.
  • Engage in co-creation.
  • Lead by example.

Why not also read our summary of Day 2 of the meeting?

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Written as part of a Media Partnership between ISMPP and The Publication Plan by Aspire Scientific, an independent medical writing agency led by experienced editorial team members and supported by MSc- and/or PhD-educated writers.

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What can be done to increase the transparency of real world studies? https://thepublicationplan.com/2022/08/30/what-can-be-done-to-increase-the-transparency-of-real-world-studies/ https://thepublicationplan.com/2022/08/30/what-can-be-done-to-increase-the-transparency-of-real-world-studies/#respond Tue, 30 Aug 2022 15:13:23 +0000 https://thepublicationplan.com/?p=12164

KEY TAKEAWAYS

  • Pharmaceutical companies, researchers, publishers, and medical publication professionals all have a role to play in increasing the transparency of real world data generation and dissemination.

Despite growing interest in real world (RW) evidence throughout the pharmaceutical sector, transparency surrounding generating, reporting and using RW evidence is not regulated, and clear guidance on best practice is lacking. This is the premise behind a recent perspective by Dr Remon van den Broek et al in Health Economics, Policy and Law, which outlines the results of roundtable discussions between pharmaceutical companies, academia and other stakeholders, including the International Society for Medical Publication Professionals, on RW transparency issues and proposes potential solutions.

“A truly transparent healthcare sector will only evolve if all stakeholders increase their efforts and bring about tangible changes resulting in greater transparency surrounding the generation and reporting of RW studies.”

As a first step to improve openness, the authors suggest adopting universal definitions for RW studies, RW data and RW evidence, with the latter defined as RW studies that have been publicly communicated or assessed for relevance and quality.

Additional recommendations for industry, researchers, decision-makers, and other involved stakeholders include:

  • engaging patients/caregivers in defining RW outcomes of interest and ensuring the engagement process is transparent
  • mandatory registration of RW studies and their protocols, with results of RW studies made available within 1 year of study completion
  • dissemination of RW studies through peer reviewed publications, with manuscripts prepared clearly and transparently and according to the most relevant methodology guidelines
  • journals expanding their expertise to provide appropriate peer review for RW studies
  • development of a RW-specific communication reporting checklist
  • provision of open access lay summaries of RW studies in journals
  • use of appropriate methodology and good assessment practices by healthcare decision-makers during the drug approval/appraisal process to ensure accurate evaluation of RW evidence
  • closer collaboration of regulatory agencies with patient communities during decision-making processes.

The authors believe that “a truly transparent health care sector will only evolve if all stakeholders increase their efforts and bring about tangible changes resulting in greater transparency surrounding the generation and reporting of RW studies”.

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What do you think - should the transparency of real world evidence more closely match that expected from clinical trials?

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Meeting report: summary of Day 3 of the 2022 ISMPP Annual Meeting https://thepublicationplan.com/2022/05/25/meeting-report-summary-of-day-3-of-the-2022-ismpp-annual-meeting/ https://thepublicationplan.com/2022/05/25/meeting-report-summary-of-day-3-of-the-2022-ismpp-annual-meeting/#respond Wed, 25 May 2022 10:03:48 +0000 https://thepublicationplan.com/?p=11544

The 18th Annual Meeting of the International Society for Medical Publication Professionals (ISMPP) took place in Washington, DC on 9-11 May and was themed ‘Future-Ready Medical Communications’.  This year, 595 attendees participated in the meeting, which was held in-person for the first time since 2019.

The meeting covered a range of topics through thought-provoking and engaging keynote addresses, oral presentations, interactive sessions and roundtables. A summary of the third day of the meeting is provided below to benefit those who were unable to attend the meeting, and as a timely reminder of the key topics covered for those who did.

Read our summaries of Day 1 and the morning and afternoon sessions of Day 2 of the meeting.

Summaries of Day 3

Good Publication Practice 4 (GPP4): Major changes, lessons learned, and next steps


KEY TAKEAWAYS
  • GPP4 has been restructured to aid day-to-day usability and training for new members of the profession.
  • GPP4 will include key updates with respect to authorship, working with patients, preprints, enhanced content, and social media.

The first session on the final day of the meeting was an eagerly anticipated discussion about the development of GPP4, moderated by Lisa DeTora (Hofstra University) with panellists Faith DiBiasi (Otsuka), Laura Dormer (Future Science Group), and Eline Hanekamp (Excerpta Medica).  All the speakers were GPP4 Steering Committee members.

DeTora noted that the GPP4 manuscript was recently submitted for journal review: as such, the panellists were able to provide an overview of the document during this session. Reflecting on the GPP4 development process, DeTora noted that while negative attention surrounding the profession during the preparation of GPP3 guided its development, GPP4 has been written in a much more positive environment, as demonstrated by the coverage of ISMPP and the profession in the recent Advancements with Ted Danson segment. The profession is also growing year-on-year, with new people entering the industry and the scope of publication types expanding. DeTora explained some changes to the structure of GPP4 compared with GPP3, noting that GPP4 aims to provide a more detailed introduction to the field to make processes more understandable for stakeholders we work with, as well as to provide a platform for training new entrants to the profession. GPP4 clarifies that standard operating procedures (SOPs), policies, and team education are part of the role of the publication professional. To help with the day-to-day usability of GPP4, the structure is more unified across the document, with more accessible and digestible sections for different topics and stylistic changes to improve consistency and remove redundancies. DiBiasi noted that SOPs and policies should not require drastic updates in light of GPP4, but the structure should facilitate the refinement or development of SOPs for companies that do not have these in place already. GPP4 is not proscriptive, but should support publication professionals in their different contexts.

A significant proportion of the audience had participated in reviewing GPP4, with 122 sets of comments received from ISMPP member groups and 38 sets of invited expert reviews. DeTora thanked reviewers for their valuable comments, many of which highlighted areas that required clarification, and all of which the GPP4 Steering Committee aimed to address. GPP4 aims to reflect what is best for the entire community, based on member input. Dormer also pointed out that, from the journal perspective, involvement in GPP4 development has been a very valuable process as it is important for publishers to be aware of guidelines so that their instructions for authors can be aligned.

DeTora and the panellists gave an overview of some of the key topics updated in GPP4:

  • Aligning with the updated International Committee of Medical Journal Editors (ICMJE) recommendations on authorship: wording has been updated around the number of authors, as ICMJE recommendations no longer suggest any limits. In recognition of potential difficulties when journals do limit the number of authors, GPP4 will provide some recommendations and signpost to resources that can help to guide author selection and order.
  • Working with patients: this key theme for publication professionals is addressed in GPP4, ensuring that the value of patient expertise is respected and providing guidance that should be useful for both the pharmaceutical industry and agencies. Patients have different backgrounds, so publication professionals may need to provide assistance to ensure that patients can reach their full potential for contributing as authors.
  • Preprints: it was a challenge to come to a balanced position on preprints, as one size does not fit all. GPP4 will recommend avoiding preprints as a routine part of publishing key clinical trial data that will form part of the product label, unless required by the journal or for urgent medical purposes; however, there are many scientific areas in which preprints are well-established within the publishing paradigm, particularly in basic research fields. The panel advised that some journals increasingly encourage posting on preprint servers, so caution may be required during submissions if this is not the intention.
  • Enhanced content: this is becoming increasingly popular, relevant, and valuable, and improves accessibility of publications for different audiences. It is crucial that any enhanced features, including plain language summaries (PLS), reflect the original content accurately and are not commercial in nature. Development of enhanced content should follow the same processes and guidelines as the original, be built into publication plans from the start, and be considered when identifying target journals.

 

It is crucial that any enhanced features, including plain language summaries (PLS), reflect the original content accurately and are not commercial in nature.

  • Social media: social media posting does not belong with the job of the publication professional. Regulatory environments differ based on location and employer, so local laws and appropriate channels should be followed (in biopharmaceutical companies, this may require consulting with public relations, commercial, legal, and regulatory; for academia, institutional policies should be adhered to). Dormer noted that journals may request social media content, but nobody should feel obliged to use social media if they do not believe it is appropriate; company policies should be followed.

 

Regulatory environments (related to social media) differ based on location and employer, so local laws and appropriate channels should be followed.

Following the panel discussion, further interesting points were raised in the Q&A:

  • To help incorporate different cultural perspectives and pressures, one of the Steering Committee members was from the Asia-Pacific region, and some language reflecting inclusivity in a broad sense is included in GPP4. The guidance should be adaptable enough to apply to different regions, and perhaps stakeholders might, in the future, look to provide guidance on applying GPP4 to the Asia-Pacific region (as was done for GPP3). Ultimately, best practice is best practice, regardless of region, so the guidance is provided without caveats to strive for as a target globally.
  • As some high-tier journals may be less willing to engage with GPP4 and ISMPP, or developments such as PLS and enhanced content, hopefully documents like GPP4, continued uptake of enhanced content at other journals, and patient and healthcare professional (HCP) use of PLS will lead to a recognition of the demand and a change in approach. In the meantime, plain language summaries of publications (PLSPs), standalone PLS of an original publication, may be considered if a PLS is not permitted by the publisher of the original article.
  • Future iterations of GPP may tackle topics like artificial intelligence and all-digital communications as industry practices in these areas continue to develop.

Publication guidelines roundtable session

During this session, attendees were able to select from 5 roundtables, each of which were focused on a different set of publication guidelines:

  • CHEERS (Consolidated Health Economic Evaluation Reporting Standards 2022)
  • ICMJE (International Committee of Medical Journal Editors) Recommendations
  • GPP4 (Good Publication Practice 4)
  • ACCORD (ACcurate Consensus Reporting Document)
  • CONSORT (Consolidated Standards of Reporting Trials).

Attendees could then join the parallel session of their choice.

Non-clinical publications: Leveraging HEOR and RWE publications across the product lifecycle

In this parallel session, Charlotte Singh (Sanofi) and Rebecca Hahn (KJT Group) explained how product data are collected throughout the lifecycle of a drug or therapy and are provided from a range of sources beyond registrational studies. They highlighted strategic takeaways for non-clinical publications:

  • agreement on strategy for communication at each phase of development
  • publications build the overall value proposition for the product
  • cross-functional alignment is necessary to provide consistent, cohesive messaging.

It was pointed out that health economics and outcomes research (HEOR) and real world evidence (RWE) studies are conducted and publications are developed across the product lifecycle, from Discovery to Prelaunch and Launch (eg, quality of life study publications, comparative effectiveness and safety, disease and treatment burden) to Growth and Maturity (eg, budget impact models, registry studies, electronic health records and claims registries). Other non-clinical publications were also discussed, like market shaping and thought leadership publications (eg, review articles, patient journey mapping, patient preference, and disease and treatment burden).

Consequently, the scope and complexity of publication plans and strategies have evolved to account for these wide datasets. Several future considerations for more thoughtful strategic communication were raised: the increased need for cross-functional execution, for publication teams to serve as strategic partners, and for medical communications involvement early on and across the product lifecycle.

Guided Poster Tour: Patient Centric Issues

The guided poster tour focused on the following posters (the presenting authors are shown in bold):

  • Do healthcare professionals really value plain language summaries? (ENCORE) – Dawn Lobban, Jacqui Oliver, Marissa Buttaro, David Falleni and Melissa McGrath (Presenter: Amanda Boughey)
  • Reviewing scientific publications to protect the privacy of clinical study participants (ENCORE) – Colin McKinnon, Friedrich Maritsch, Ingeborg Cil, Nicole Baumgartner, Jesse Potash, Borislava Pavlova, Valérie Philippon
  • Reporting of patient-reported outcomes in the peer-reviewed literature from the mid-1990s to present day –Lisa Feder, Samantha Rivera and Larry Radican

 Defining metrics that matter


KEY TAKEAWAYS
  • When choosing metrics, start with the objective of what you want to measure rather than what you can measure, stay aware of expanding/changing metrics to ensure the best selection of those aligned with your objectives, and embrace new technological developments, such as automated dashboards, to achieve objectives.

The need to quantify impact, and return on investment, of publications is universal, and yet there is no consistently used, established, standard metric. In this parallel session, Neil Adams (Karger Publishers), Jennifer Ghith (Pfizer) and Todd Parker (MedThink SciCom) explored how we can evaluate our publication activities to improve performance of data dissemination.

Defining meaningful metrics

Firstly, we need to define the objective of the metric assessment. For example, this could be amplification of publication reach or identifying a publication gap. Once the objective of the metric is established, this can be used to identify the best metric to use.

Ask yourself:

  • what do you want to understand?
  • how can you measure it?
  • who is your audience?
  • how can metrics be optimised and disseminated?
  • what are you going to do with the information?
Assessing reach through the use of tactical metrics

Current metrics measure 3 factors: impact (eg Journal Citation Reports,), reach (eg views and downloads), and speed (time to decision, time to publication).

Many metrics are already available from journals in the form of metrics dashboards, such as that of NEJM and Elsevier. However, it is best to consider what you want to measure rather than what you can measure, and then see if this matches up with available metrics; it is always an option to reach out to publishers, as metrics such as time spent on page may not be routinely available but can usually be obtained upon request.

The current metrics landscape provides many ways to analyse how readers interact with publications. However, the truth behind the metrics can be complicated. Take, for example, the concept of ‘stickiness’ – if a person stays on the page for a long time, it could be that they were engaged, or it could be that the manuscript was confusing. Equally, an increase in social activity around a publication can be good or bad – not all news is ‘good news’.

Metrics that measure social media feeds must evolve and reflect new targets and platforms.

Metrics that measure social media feeds must evolve and reflect new targets and platforms. Bibliographic platforms such as Mendeley that allow users to quickly download publications to their library for later engagement, record a short period of attention/engagement, while summary download metrics, such as Altmetric, don’t record whether an article was later read or not. Similarly, the livestream conversation feeds for the ISMPP Annual Meeting have moved from Twitter to Whova – illustrating how metrics capturing social media activity must be flexible to change with user behaviour.

Knowledge- or behavioural-based metrics

As well as measuring the impact and reach of publications, it is important to gauge how these affect the knowledge and behaviour of the medical community. Although a publication may have a high impact factor in terms of views and citations, this does not reveal the sentiment of the ‘interaction’ with the publication. Tools such as Scite harnesses artificial intelligence to automatically assign the context of a reference citation as ‘supporting’, ‘contrasted’, or ‘neutral’. However, a pilot trial by Karger Publishers of 8-10 journals found that most results were classified as ‘neutral’ which wasn’t very informative.

The EMPIRE Index from PloS One addresses some perceived inadequacies of the current metrics landscape, such as the arbitrary weighting behind the Altmetric attention score, to include societal and social impacts. Using qualitative metrics such as these will be important when justifying future publication initiatives to colleagues.

Forward-thinking metrics

Engaging with colleagues from more active analytical functions (such as commercial and data analytics teams) can yield further insight into the best way to measure publication success and appropriate metrics. However, it is unlikely that one solution will provide all the information required to assess whether all publication objectives have been achieved.

An ABC set of criteria for establishing a framework for forward-thinking metrics was presented:

  • Accuracy – does the chosen metric really measure what is to be assessed? One should be wary of social media activity counts, which may not indicate whether learning has taken place, and third-party sites that amalgamate multiple metrics, as these may not show the full picture.
  • Brevity – use small amounts of data that require medics to transfer from one site to another, telling a story and in the process, measuring engagement and retention with that story.
  • Consistency – be consistent with what you measure and how you measure over time to obtain the most meaningful metrics.

It was noted that the best metrics are:

  • responsive to change
  • long-lasting
  • tied to business value and the target audience.

As well as optimising the metrics we use to evaluate interaction with publications, we should also be working to measure the findability of our data.

As well as optimising the metrics we use to evaluate interaction with publications, we should also be working to measure the findability of our data. Globally, HCPs spend ≥1.5 h a day on online research, and if they can’t find the data, then the metrics won’t matter. Article volume has increased, which can lead to information overload, making it difficult to find content and gain share of voice.

At the end of the session, the panel answered questions from the audience. Regarding the need for benchmarking the effect of a publication and the difficulty of interpreting metrics such as article download numbers, the panel suggested benchmarking against articles in the same issue of the journal. However, they cautioned that a lot of data need to be assimilated to achieve in-depth benchmarking. When asked if they use metrics to inform their publication plans, the panel responded that metrics were used to inform journal choice, and to see if the development of article enhancements are worth continuing. Lack of consistency in metrics reporting between publishers was raised, particularly with regard to page views, but the panel were able to confirm that there are as yet no discussions among publishers about having a consistent metrics platform, so authors/publication managers will still have to contact journals for this information on an individual basis. ISMPP provides several resources about best practice for metrics assessment, such as reports from the Social Media & Web-Based Metrics Working Group, which can inform journals, as well as industry members and authors.

Behind the infographic magic: How strategic cross-functional collaboration drives better content and engagement


KEY TAKEAWAYS
  • Infographics are effective tools to deliver scientific messages. Cross-functional collaboration between stakeholders and enhanced visualisation of data are key to refine infographic content and boost audience engagement.

In this parallel session, Gerry Johnson (ICON), Amy O’Connell (ICON), Tanya Brinsden (ICON) and Maya Shehayeb (Amgen) presented a strategic approach to developing infographics, combining design principals with data translation using enhanced visualisation.

Data show that people scan scientific posters for no more than 20 seconds before deciding whether to read on in more detail. Lots of dense text and figures can bury the important scientific message, meaning they get missed.

Lots of dense text and figures can bury the important scientific message, meaning they get missed. Infographics are an effective tool to quickly capture an audience’s attention.

Infographics are an effective tool to quickly capture an audience’s attention and allow data to come through clearly. Pairing design principles, ie clear communication and an organised story, with enhanced visuals helps to translate data, increase audience engagement, and drive impact. Cross-functional collaboration between scientific, creative, and other key stakeholders is a crucial component to the success of this process.

Understanding how an audience comprehends information is an important first step. Visual iconography can help draw an audience and aid their comprehension by acting as a mental shortcut. Of equal importance is an appreciation of what types of visual aids work best in different venues: what works well in a small room may not work well in a large auditorium.

The speakers outlined a phased process of developing infographics with an enhanced visual approach:

  • Evaluation and planning – assess the audience and venue to identify the major points to be presented (use links and/or supplemental materials for complete data). Consider the layout and organisation of data.
  • Translation – translate data using an enhanced visual approach to improve comprehension without oversimplifying (eg iconography, visual hierarchy, interactivity, and graphical visualisation).
  • Refinement – check that the content is reading correctly, and it is an accurate representation, then edit and re-evaluate.
  • Review and approval – seek approval from key stakeholders and ensure the layout is fact checked before submitting for medical and legal review. Incorporate any final edits.

Enhanced visual approaches are well received by audiences and metrics demonstrate that the increased investment is well spent in terms of impact and readership.

Testimonials have shown that an enhanced visual approach is well received by audiences and although budgetary and time constraints can be barriers to implementation, metrics demonstrate that the increased investment is well spent in terms of impact and readership.

ISMPP Authorship Algorithm Showcase


KEY TAKEAWAYS
  • The ISMPP Authorship Algorithm Tool will soon be available for use via the ISMPP website.
  • Based on a clear interpretation of ICMJE criterion #1, the tool can assist publications professionals with conversations and decisions surrounding authorship eligibility.

As previewed during this year’s ISMPP European Meeting, the ISMPP Authorship Algorithm Tool will soon be available for publication professionals to use, following testing and feedback on the pilot version. Karen Mittleman (member of the ISMPP Authorship Algorithm Task Force) opened the session with a historical perspective on how the ICMJE authorship criteria are related to Good Publication Practice, noting the age-old challenge of defining and quantifying authors’ contributions against ICMJE criterion #1. This issue led to the creation of the ISMPP Authorship Task Force. As described by Maggie Hodgson (Merck & Co.), and as later highlighted by Rob Matheis (ISMPP President and CEO), practical guidance on this matter has been long overdue.

[So many of the questions I receive] are all about authorshipwhat are we going to do, how do we know if this person qualifies [for authorship] or not? So [the tool] was kind of an obvious thing to do that was long overdue.” – Rob Matheis, ISMPP President and CEO

Scott Thompson (Acceleration Point) outlined some of the technology under the hood of the online tool, which has been designed to easily integrate into users’ existing Microsoft ecosystems, along with forthcoming implementation aids that will be available to users on the website. Thompson then handed over to Jeff Clemens (Eli Lilly) who presented a video demonstration of the tool. Clemens walked through the steps required to set up a project, choose the appropriate weightings for the algorithm based on the type of project, and ultimately generate objective contribution scores for each potential author against the various facets of ICMJE criterion #1.

With the website soon to be up and running, Sonia Schweers (Bristol Myers Squibb) closed the session with a call to action, appealing for people to use the tool. Schweers noted that the more the tool is used in discussions surrounding authorship, the better it will become (through updates based on user feedback) and the easier it will be to implement as it gains credibility among the biomedical publishing community.

Why not also read the summaries of Day 1 and the morning and afternoon sessions of Day 2 of the meeting?

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Written as part of a Media Partnership between ISMPP and The Publication Plan, by Aspire Scientific, an independent medical writing agency led by experienced editorial team members, and supported by MSc and/or PhD-educated writers.

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An interview with Valérie Philippon: beyond clinical trial data https://thepublicationplan.com/2022/05/16/an-interview-with-valerie-philippon-beyond-clinical-trial-data/ https://thepublicationplan.com/2022/05/16/an-interview-with-valerie-philippon-beyond-clinical-trial-data/#respond Mon, 16 May 2022 13:10:39 +0000 https://thepublicationplan.com/?p=11310

While randomised clinical trials are often considered the gold standard of medical research, data generated from other settings can provide highly valuable findings and should be considered when developing a publication plan. Following her presentation at the 2021 International Society for Medical Publication Professionals (ISMPP) West meeting, The Publication Plan talked to Valérie Philippon, Head of Global Publications at Takeda, to find out more about the benefits of including non-clinical trial research in publication strategies.

At the ISMPP West meeting in October 2021, we heard how data from outside clinical trial settings – such as observational research and health economic analyses – can add value to a publication strategy. What gaps can these data fill and what are the benefits of incorporating them into publication strategies?

“To develop an impactful and complete publication plan, one has to consider all types of data: not only the clinical data but also preclinical, heath economics and outcomes, and real-word evidence. Doing an in-depth gap analysis of a particular disease area is a really important first step in developing a publication plan, followed by identifying all relevant audiences and mapping out data availability. Clinical data are of course designed to answer key questions about a particular intervention, but not all medical questions can be answered by randomised clinical trials, since not all populations can be studied at once. Observational studies can shed light on many disease parameters and outcomes research can help understand how patients experience health care interventions. These findings should be incorporated into publication plans.”

To develop an impactful and complete publication plan, one has to consider all types of data.”

In your experience, what are the most important things to understand about these types of datasets? How do they differ from clinical trial data?

“Understanding the differences between controlled trials and observational studies is key to interpreting data and comprehending the limitations of the studies. In clinical trials, individuals are assigned to receive one or more interventions (or no intervention) so that the effects of the interventions on biomedical or health-related outcomes can be evaluated; whereas observational study participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions. One limitation of observational studies is selection bias, as individuals in a database or study are not randomly assigned to an active or control group, but generally have already been diagnosed with the disease being studied and/or are receiving a specific treatment, making any attempt to control variables difficult. However, such studies can be very large and span multiple years leading to rich datasets. The two types of study are complementary and should both be included in publication planning.”

Are there any best practice tips you could share on how to incorporate value communications into a publication plan?

A coherent value communication, scientifically driven and relevant to each audience, should be developed early and updated frequently.”

“A coherent value communication, scientifically driven and relevant to each audience, should be developed early and updated frequently as more data are generated. Understanding the current landscape, identifying the needs of each audience and mapping out data availability are all key components to take into account while building a publication plan incorporating strategic data release.”

We also heard how the target audiences for value communications may include decision makers, payers, and patients, in addition to healthcare practitioners (HCPs). How do the needs of the end-users differ and how should that impact the publication planning approach?

“A publication plan must target all relevant audiences, in terms of type of communication, venue and timing. HCPs need safety and efficacy information in order to inform their diagnostic and treatment decisions, while payers need economic and outcome data to help them with reimbursement decisions. Understanding the payers’ needs is critical for a company to ensure that key information is communicated early enough for its innovation(s) to translate into patient value and access.”

There’s growing recognition of the importance of making medical publications accessible to a wider audience through instruments such as plain language summaries (PLS). What are your perspectives on how the industry can innovate and adopt policies to achieve this goal? What should we as publication professionals be doing to communicate more effectively with a non-HCP audience?

“Scientific literature is by definition technical and difficult to understand for non-specialists and more can be done to make scientific and medical research more accessible and inclusive. Plain English and lay summaries of peer reviewed medical journal publications are intended for everyone engaging with medical research, such as all HCPs (MD and non-MD, specialists and general practitioners), patients, patient advocates, caregivers, and the general public. More and more PLS are developed alongside medical publications and indexed in PubMed, but we can still do better at consistently developing PLS, and agree as an industry on their format (eg, length, inclusion of infographics), the process involved in writing PLS and how to make PLS discoverable.”

More can be done to make scientific and medical research more accessible and inclusive.”

At the ISMPP EU 2022 meeting you co-authored a study on the accessibility of pharmaceutical industry-sponsored research. Do you think universal open access for pharma-sponsored research is an achievable goal? What’s the current approach to open access at Takeda?

“As a commitment to transparency and to open science, Takeda requires the submission of all Takeda-supported research manuscripts to journals that offer public availability via open access, allowing the public to obtain free, unrestricted online access to Takeda’s research promptly following publication. On a personal level, I believe that universal open access for pharma-sponsored research is a very attainable goal that all pharmaceutical companies should prioritise.”

I believe that universal open access for pharma-sponsored research is a very attainable goal that all pharmaceutical companies should prioritise.”

You have also been involved in research on the utilisation of preprints by the pharmaceutical industry, which to date has been relatively limited. Do you envisage greater use of preprint servers by the industry in the future? Are there any fundamental barriers preventing the pharma industry from using preprints?

“As we demonstrated in our ISMPP posters (Current trends in pharmaceutical industry-affiliated preprints, Wieting et al, presented at the 2021 ISMPP European Meeting and Current trends in pharmaceutical industry-affiliated medRxiv and bioRxiv preprints, Wieting et al, presented at the 2022 ISMPP European Meeting), only a small proportion of preprints are affiliated with pharmaceutical companies and even fewer have a pharmaceutical employee as first or corresponding author. There is a reluctance to share clinical data in preprint form as some companies feel that preprints fall outside of the scientific exchange, so more guidance from regulatory bodies would be helpful.”

“Some companies feel that preprints fall outside of the scientific exchange, so more guidance from regulatory bodies would be helpful.”

Valérie Philippon is Head of Global Publications, Takeda, and can be contacted via valerie.philippon@takeda.com or LinkedIn.

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In your experience, how often do scientific publication plans include data from research beyond clinical trials?

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Long COVID: the lasting impact of the COVID-19 pandemic on the scientific community https://thepublicationplan.com/2022/03/15/long-covid-the-lasting-impact-of-the-covid-19-pandemic-on-the-scientific-community/ https://thepublicationplan.com/2022/03/15/long-covid-the-lasting-impact-of-the-covid-19-pandemic-on-the-scientific-community/#respond Tue, 15 Mar 2022 10:03:29 +0000 https://thepublicationplan.com/?p=10960

KEY TAKEAWAYS

  • The rate of new research projects initiated in 2020 decreased versus the start of the pandemic, disproportionally affecting female scientists and those with young children.
  • The amount of time spent on research has almost returned to
    pre-pandemic levels.

The ongoing, global impact of the COVID-19 pandemic is well documented, but how has the scientific community been affected in the long term? Dr Jian Gao and colleagues surveyed almost 7,000 US- and European-based scientists in April 2020 and again in January 2021 to assess the long-term effects of the pandemic on their work.

The proportion of scientists not initiating a new research project tripled from 9% in 2019 to 27% in 2020. Although the impact was consistent across different scientific fields, the survey found that female scientists and those with young children were disproportionately affected, echoing previous reports that gender inequality has been exacerbated during the pandemic. A third of survey respondents worked on COVID-19-related research in 2020 and saw no change in pre-pandemic productivity, reflecting the widespread response to the pandemic within the scientific community.

How has this impact on research affected the publication output of scientists? Using the Dimensions dataset, Dr Gao and colleagues analysed rates of new co-authorships in 2019 versus 2020. Unsurprisingly, new co-authorships on COVID-19-related papers increased by 40%. Conversely, new co-authorships on non-COVID-19-related papers decreased by around 5%. The latest figures also suggest the time scientists are spending on research is returning to normal, with only minor differences in total work time in 2021 versus pre-pandemic, compared with the sharp decline reported in 2020.

It is clear from this survey that scientists are still being affected by the COVID-19 pandemic.

Although the impact of the pandemic appears to have lessened over time, it is clear from this survey that scientists are still being affected by the COVID-19 pandemic, with fewer new research projects being initiated. As these effects are likely to be long-lasting, action from institutional leaders and funders is needed to avoid serious effects on research.

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Has your work been impacted in the long-term by the pandemic?

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[VIDEO] Involving the patient from protocol to publication in real-world evidence studies https://thepublicationplan.com/2021/10/21/video-involving-the-patient-from-protocol-to-publication-in-real-world-evidence-studies/ https://thepublicationplan.com/2021/10/21/video-involving-the-patient-from-protocol-to-publication-in-real-world-evidence-studies/#respond Thu, 21 Oct 2021 10:35:55 +0000 https://thepublicationplan.com/?p=10138 In this webinar recorded in September 2021, a panel including Emma Bagshaw, Mark Larkin and Sam Llewellyn from Vitaccess and Fulvio Baggi, Director of The European Myasthenia Gravis Association, discussed the lifecycle of creating collaborative digital patient registries and taking them through to publications. The discussion was based on the MyRealWorld Myasthenia Gravis study, which was co-created with patient advocacy groups and key opinion leaders from 9 countries.

Recorded 22 September 2021 as a MedComms Networking webinar. Produced by NetworkPharma.tv

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