Best practice – 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, 01 Oct 2025 08:25:25 +0000 en-US hourly 1 https://s0.wp.com/i/webclip.png Best practice – The Publication Plan for everyone interested in medical writing, the development of medical publications, and publication planning https://thepublicationplan.com 32 32 88258571 Wiley develops AI guidelines in response to demand from researchers https://thepublicationplan.com/2025/10/01/wiley-develops-ai-guidelines-in-response-to-demand-from-researchers/ https://thepublicationplan.com/2025/10/01/wiley-develops-ai-guidelines-in-response-to-demand-from-researchers/#respond Wed, 01 Oct 2025 08:25:23 +0000 https://thepublicationplan.com/?p=18314

KEY TAKEAWAYS

  • Wiley embraces a future-looking AI policy with guidelines on responsible and ethical use, with human oversight, to ensure the integrity of publications.
  • The guidelines also provide tips on how AI can be used, effective prompt engineering, and choosing the best AI tools for the project.

Artificial intelligence (AI) is becoming more widely adopted within scientific publishing, yet many authors remain unsure how to use it effectively while maintaining the integrity of their research. Highlighted by an article in Research Information, Wiley have released AI guidelines for book authors in response to findings that ~70% of researchers want publisher guidance on using AI.

The guidelines include:

  • Reviewing terms and conditions: authors should regularly review terms and conditions to ensure that their chosen AI technology does not claim ownership over the content or limit its use.
  • Maintaining human oversight: AI should assist but not replace authors. Authors must take full responsibility for their work and review any AI-generated content before submission.
  • Disclosing AI use: authors should document all AI use, including its purpose and impact on findings, and describe how AI-generated content was verified.
  • Ensuring protection of rights: authors must ensure that the AI used (or its provider) does not gain rights over the authors’ material, including for the purposes of training the AI.
  • Using AI responsibly and ethically: authors must comply with data protection laws, avoid using AI to copy the style or voice of others, fact-check the accuracy of AI-generated content, and be mindful of potential biases.

The guidance also provides recommendations on how to write prompts and select AI tools, as well as suggestions on use cases for authors newer to AI:

  • analysing research and recognising themes across sources
  • exploring ways to simplify complicated topics
  • adapting work so it is relatable for different audiences
  • polishing work by refining language and checking for consistency.

The guidelines complement Wiley’s existing generative AI framework for journal publications. As stated by Jay Flynn (Wiley EVP & General Manager, Research & Learning), “writers and researchers are already using AI tools, whether publishers like it or not. At Wiley, we’d rather embrace this shift than fight it”.

“Writers and researchers are already using AI tools, whether publishers like it or not. At Wiley, we’d rather embrace this shift than fight it”
– Jay Flynn, Wiley EVP & General Manager, Research & Learning

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What do you think – should publishers give authors more guidance on how to use AI appropriately?

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ISPEP releases white paper questioning pharma’s patient engagement promises https://thepublicationplan.com/2025/09/10/ispep-releases-white-paper-questioning-pharmas-patient-engagement-promises/ https://thepublicationplan.com/2025/09/10/ispep-releases-white-paper-questioning-pharmas-patient-engagement-promises/#respond Wed, 10 Sep 2025 14:59:28 +0000 https://thepublicationplan.com/?p=18287

KEY TAKEAWAYS

  • ISPEP’s white paper argues that pharmaceutical companies must move beyond superficial patient centricity to establish genuine, long-term collaborative relationships.
  • ISPEP presents 5 strategic recommendations to transform how industry engages with patients throughout drug development lifecycles.

The International Society for Patient Engagement in Publications (ISPEP) has published a white paper challenging pharmaceutical companies to honour their commitments to meaningful patient involvement. Authors Chris Gray, Rob Wyer, and Steve Clark argue that while many organisations have embraced patient-centric rhetoric, implementation often falls short and risks alienating the very people it aims to support.

The authors highlight a growing disparity between pharmaceutical companies’ public commitments and patients’ experiences. Survey data reveal a stark perception gap: while 72% of industry employees agreed with the statement “My company communicates with care and compassion, transparent and unbiased information on diseases, treatment options, and available resources”, only 32% of patients agreed.

“Survey data reveal a stark perception gap: while 72% of industry employees agreed with the statement “My company communicates with care and compassion, transparent and unbiased information on diseases, treatment options, and available resources”, only 32% of patients agreed.”

The authors highlight that regulatory authorities are ahead of pharma when it comes to patient engagement: both  the Food and Drug Administration and European Medicines Agency expect patient involvement in the drug development process and consult directly with patient groups and individuals.

Five strategic priorities for revolutionising patient collaboration

The white paper presents a comprehensive framework built around 5 key recommendations:

  1. Maintain continuity across the lifecycle

Organisations should ensure lifecycle continuity by establishing sustained partnerships that transcend departmental boundaries. Many companies fail to maintain relationships once specific studies conclude, despite patients requiring ongoing support. In addition, patients may become frustrated when requests come from multiple departments.

  1. Build a legacy

Companies should establish enduring impact through collaborative, multi-sponsor initiatives that protect patient communities from development setbacks or shifting corporate priorities.

  1. Elevate patient advocacy

Pharmaceutical companies must champion patient representation internally by embedding patient perspectives within core business strategy with executive leadership backing.

  1. Measure and report progress

Companies should implement robust systems to track and communicate outcomes using comprehensive evaluation frameworks that combine qualitative insights with quantitative metrics.

  1. Challenge, reinterpret, and rewrite SOPs

Finally, organisations must reform standard operating procedures (SOPs) that may inadvertently restrict meaningful patient collaboration.

The authors conclude that as patients are the end users, they ultimately determine the success of new therapies. Developing and maintaining patient collaborations will help to overcome the disconnect between patient and pharma needs and improve outcomes for all stakeholders.

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Do you think pharmaceutical companies are genuinely committed to meaningful patient engagement?

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ChatGPT and peer review: risk or revolution? https://thepublicationplan.com/2025/04/01/chatgpt-and-peer-review-risk-or-revolution/ https://thepublicationplan.com/2025/04/01/chatgpt-and-peer-review-risk-or-revolution/#respond Tue, 01 Apr 2025 14:51:13 +0000 https://thepublicationplan.com/?p=17474

KEY TAKEAWAYS

  • AI-generated peer reviews are increasingly common, but they often lack depth and true scientific insight.
  • Responsible AI use can support, but not replace, expert human review, but clear guidelines and transparency are needed to maintain scientific integrity.

A recent article by James Zou in Nature highlights the growing role of AI in peer review, where up to 17% of peer-review comments in a sample of computer-science reviews were AI generated. While tools like ChatGPT can assist with reviewing research papers, they also present challenges that the academic community must address.

The growing use of AI in peer review

Since the rise of ChatGPT in 2022, researchers have observed an increase in AI-generated peer reviews. These reviews are often characterised by a formal, verbose style and often do not refer specifically to the content of the submitted paper. Zou’s study, which analysed 50,000 peer reviews, also found that AI-generated text was more common in last-minute reviews, suggesting that time constraints may drive its use.

Risks and limitations of AI in peer review

While AI can streamline certain peer-review tasks, it cannot replace expert human reviewers. Current large language models (LLMs) struggle with deep scientific reasoning and can often generate misguided assessments or ‘hallucinations’. AI-generated feedback can also lack technical knowledge and may overlook critical methodological flaws. Even when AI tools are used for low-risk applications, such as retrieving or summarising information, they can be unreliable, and all AI outputs should be verified by human reviewers. Platforms like OpenReview, which facilitate interactive discussions between authors and reviewers, offer a promising model for balancing AI assistance with human oversight.

Responsible AI use in peer review

Zou concludes that the adoption of AI in academic publishing is inevitable. Instead of banning AI, the scientific community must establish guidelines for its responsible use.

Instead of banning AI, the scientific community must establish guidelines for its responsible use.

To maintain scientific integrity, journals and conferences should require reviewers to disclose AI usage and develop policies that limit AI’s role to supportive, rather than decision-making, functions. More research is needed to define best practices, ensuring that AI benefits peer review without compromising its core principles.

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How should journals handle AI-generated reviews?

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AI in SLRs: a tool, not a replacement https://thepublicationplan.com/2025/01/29/ai-in-slrs-a-tool-not-a-replacement/ https://thepublicationplan.com/2025/01/29/ai-in-slrs-a-tool-not-a-replacement/#respond Wed, 29 Jan 2025 16:23:32 +0000 https://thepublicationplan.com/?p=17112

KEY TAKEAWAYS

  • AI can enhance efficiency at every stage of SLR development, facilitating projects of scale that may previously have been unfeasible.
  • Use of AI in SLRs requires human oversight to ensure quality, transparency, reproducibility, and accuracy, with authors remaining accountable for their work.

As the demand for up-to-date systematic literature reviews (SLRs) grows, artificial intelligence (AI) is an increasingly appealing tool given its efficiency and ability to manage a vast evidence base. In their article for the International Society for Medical Publication Professionals (ISMPP), Polly Field, Thomas Rees, and Richard White highlight the benefits of AI in SLRs and key considerations for its use.

Benefits and pitfalls of AI

AI tools can streamline SLRs by analysing large datasets, summarising and grouping data, identifying patterns, and visualising findings – all in a fraction of the time it would take a team of researchers. However, careful attention must be given to how AI tools handle sensitive input data, including confidential content, copyrighted material, and personal information. Human validation remains essential to address potential inaccuracies, ‘hallucinations’, omissions, and bias produced by AI.

When and how should AI be used?

Whether and how to use AI in SLRs depends on the context. AI can help to:

  • frame research questions
  • optimise search strategies
  • screen studies
  • extract data
  • assess the quality of evidence, and
  • synthesise findings.

Different AI tools suit different stages, but the authors stress that all use of AI must adhere to strict principles of transparency, reproducibility, quality, and accuracy.

Medical publication professionals should familiarise themselves with existing guidance from the International Committee of Medical Journal Editors (ICMJE) and individual journal policies, as well as the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines on disclosure of AI use. These policies expound the following principles:

  • All authors remain fully accountable for the quality and accuracy of their work, including when AI is involved.
  • Transparency is critical – both the methods and acknowledgment sections must clearly document how and where AI was applied.

The authors emphasise that human oversight is essential, ensuring AI supports rather than replaces expert judgement.

“Human oversight is essential, ensuring AI supports rather than replaces expert judgement.”

As AI embeds deeper into SLRs, the authors encourage medical publication professionals to explore the potential use of AI in their research, while adopting key principles to ensure robust, transparent, and high-quality reviews.

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Have you used generative AI tools in your work?

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[PODCAST] A conversation with compliance https://thepublicationplan.com/2024/11/05/podcast-a-conversation-with-compliance/ https://thepublicationplan.com/2024/11/05/podcast-a-conversation-with-compliance/#respond Tue, 05 Nov 2024 15:57:03 +0000 https://thepublicationplan.com/?p=16727 The evolving role played by compliance in the medical communications industry is the topic for discussion in this episode  of the ISMPP InformED podcast series. Guest host, Cassie Stox, along with Merry Saba and Megan Weigel share their experiences and insights on company policies and procedures, publication processes and SOPs. Subscribe to the podcasts here.

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ISMPP poll: adverse event inclusion just before abstract submission – what would you do? https://thepublicationplan.com/2024/10/02/ismpp-poll-adverse-event-inclusion-just-before-abstract-submission-what-would-you-do/ https://thepublicationplan.com/2024/10/02/ismpp-poll-adverse-event-inclusion-just-before-abstract-submission-what-would-you-do/#respond Wed, 02 Oct 2024 14:19:48 +0000 https://thepublicationplan.com/?p=16518

KEY TAKEAWAY

  • When faced with an impending congress deadline, open lines of communication with all relevant stakeholders are critical to ensure conference abstracts are accurate and objective representations of scientific data.

The results of a clinical trial are often shared publicly for the first time as a conference abstract. As medical writers, we are frequently faced with ensuring accurate and transparent reporting of the trial results in the abstract, while meeting tight congress submission deadlines. A recent poll in the International Society for Medical Publication Professionals (ISMPP) MAP Newsletter asked publication professionals how they would react to a last-minute request to add in details of an adverse event to an abstract reporting the results of a clinical trial. Dr Eric Y Wong (Johnson & Johnson Innovative Medicine) broke down the results of the poll and provided additional perspective and recommendations. 

The poll asked: A medical writer worked with authors to develop a congress abstract for a Phase 2 clinical study. Two days before submission, the lead author requests an additional ‘medical narrative’ statement to be added detailing the management steps and time to resolution of an adverse event seen in one patient.

What would you do?

The results of the poll, which was answered by 67 people, were: 

  • 88.1% – Connect and discuss with relevant stakeholders to understand the request and criticality of data inclusion. Propose to the lead author that the submission be completed with the abstract as is, with the additional data to be generated and included within the congress poster/oral presentation, if accepted.
  • 10.4% – It is critical to amend the abstract. Contact the relevant stakeholders (Clinical Trial Lead, Biostats authors) immediately to obtain the relevant information. Prepare to edit the abstract, re-circulate for all-author approval, follow up with all authors, and submit the abstract – hopefully, you will still meet the deadline.
  • 1.5% – It is too late to add anything to the abstract, and the adverse event is too important to exclude from the submission. Propose to the lead author and internal stakeholders that submission of the abstract be postponed and retargeted for the next appropriate congress instead.
  • 0% – It is too late to add anything to the abstract, and you are already at the character limit. Go ahead and submit the abstract since you already received the lead author’s approval email.

Analysing the results, Dr Wong agreed with the consensus, noting that proposing the abstract be submitted ‘as is’, with the additional data to be reported in the final presentation, would be the recommended approach. Amending the abstract to include additional detail for the adverse event could give too much emphasis to a single patient’s experience and would not generally be appropriate for an abstract intended to provide an overview of the trial’s efficacy and safety results. With 2 days to the abstract deadline, Dr Wong thought there was ample time to resolve the situation and therefore postponement of the submission was not necessary. Encouragingly, none of the respondents thought that submitting the current version, which does not currently meet author approval, was a valid approach.

In summarising, Dr Wong stated the need for all involved parties to be engaged to develop an abstract that is representative of the trial results as a whole. Publication professionals can refer to any relevant company policies or steering committee charters to determine appropriate next steps if escalation is required.

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Have you ever had to postpone an abstract submission on which you’ve been involved due to last-minute content changes?

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Building trust: ACCORD guidelines for reporting consensus methods https://thepublicationplan.com/2024/07/09/building-trust-accord-guidelines-for-reporting-consensus-methods/ https://thepublicationplan.com/2024/07/09/building-trust-accord-guidelines-for-reporting-consensus-methods/#respond Tue, 09 Jul 2024 10:48:23 +0000 https://thepublicationplan.com/?p=16181

KEY TAKEAWAY

  • The ACCORD reporting guidelines comprise a 35-item checklist that aims to improve the transparency of reporting on consensus methods.

The COVID-19 pandemic highlighted the need for effective knowledge-sharing to guide healthcare decisions. In rapidly evolving situations, reaching consensus among experts from diverse backgrounds is crucial, especially when evidence is emergent or inconsistent. This process is best achieved using formal consensus methods.

Despite their critical role in healthcare and policy decision-making, consensus methods are often inadequately reported, leading to inconsistencies and lack of transparency. To address these issues, the ACcurate COnsensus Reporting Document (ACCORD) project was established to develop comprehensive guidelines for reporting the numerous consensus methods used in medical research.

The ACCORD reporting guidelines aim to enhance trust in the recommendations made by consensus panels, benefiting authors, journal editors, reviewers, and, ultimately, patients through more reliable healthcare recommendations.

The ACCORD checklist was formulated using the EQUATOR Network’s methodology for developing reporting guidelines, with the full study protocol published in Research Integrity and Peer Review. The project began with a systematic review, followed by 3 rounds of the Delphi process and several steering committee meetings. To ensure a comprehensive perspective, a diverse panel was engaged, comprising 72 participants from 6 continents and various professional backgrounds, including clinical, research, policy, and patient advocacy. Through this rigorous process, a preliminary checklist was refined to a final list of 35 essential items covering all sections of a manuscript.

The ACCORD reporting guidelines aim to enhance trust in recommendations made by consensus panels, benefiting authors, journal editors, reviewers, and ultimately patients through more reliable healthcare recommendations.

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What do you think – will the ACCORD guidelines improve the transparency of reporting on consensus methods?

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AI in scientific reporting: NASW’s position statement https://thepublicationplan.com/2024/05/21/ai-in-scientific-reporting-nasws-position-statement/ https://thepublicationplan.com/2024/05/21/ai-in-scientific-reporting-nasws-position-statement/#respond Tue, 21 May 2024 08:22:59 +0000 https://thepublicationplan.com/?p=15866

KEY TAKEAWAYS

  • NASW sets out its position on the use of AI, highlighting the importance of human writers and editors and the need for transparency.
  • NASW calls for members to follow these principles and for us all to remain vigilant in the use of AI to maintain integrity and accuracy in scientific reporting.

In the wake of organisations such as the International Society for Medical Publication Professionals (ISMPP) and Nature setting out their stance on the use of AI in medical publishing, the National Association of Science Writers (NASW) have now released their position statement on the use of generative AI tools.

Who are NASW?

NASW is a community of people who write and produce material intended to inform the public about science, health, engineering, and technology. At the forefront of NASW’s operating principles is their aim to “foster the dissemination of accurate information regarding science through all media normally devoted to informing the public”.

What is NASW’s position on AI?

In NASW’s statement, they highlight some of the current concerns around AI tools replacing human writers, including the potential for:

In light of these concerns, NASW go on to make the following commitments and recommend that members:

  • do not use generative AI tools to replace human writers and editors
  • do not support publication of content generated entirely by AI, without human input and oversight
  • do not use AI-generated images, except under very particular conditions and with safeguards in place
  • maintain transparency about the use of AI systems
  • support media unions in demanding worker protections and input into AI use.

What can you do?

NASW call on us all to “remain vigilant so that readers and writers alike can clearly distinguish between human- and algorithm-generated content”.

We must remain vigilant so that readers and writers alike can clearly distinguish between human- and algorithm-generated content.

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What do you think – should we all be following the NASW guidelines to protect writers and the public from the potential pitfalls of AI?

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LATITUDES: a free one-stop-shop for “risk-of-bias” tools https://thepublicationplan.com/2024/03/27/latitudes-a-free-one-stop-shop-for-risk-of-bias-tools/ https://thepublicationplan.com/2024/03/27/latitudes-a-free-one-stop-shop-for-risk-of-bias-tools/#respond Wed, 27 Mar 2024 10:45:11 +0000 https://thepublicationplan.com/?p=15437

KEY TAKEAWAYS

  • The LATITUDES Network provides a much-needed resource for identifying and accessing reliable validity assessment tools, for use during evidence synthesis.
  • LATITUDES is a parallel resource to the EQUATOR Network, with both acting to disseminate best practice in health research.

The LATITUDES Network was launched in late 2023 as a parallel resource to the EQUATOR Network. LATITUDES provides key validity assessment tools as part of a drive to “disseminate best methods and practice” for health research studies.

Why LATITUDES?

Although the EQUATOR Network has been instrumental in promoting transparent and accurate reporting guidelines, an equivalent resource for accessing appropriate, validated, and reliable critical appraisal tools has been lacking to date. These tools, also known as validity assessment tools, assess study quality in terms of:

  • risk of bias or systematic error
  • applicability of findings to real-world settings
  • reporting quality.

How will LATITUDES help?

The LATITUDES Library lists tools that meet 4 specified inclusion criteria, such as being applicable to the wider research community, and assessing multidimensional aspects of validity within a study. Those which fulfil an additional 4 criteria are designated LATITUDES key tools. These tools:

  • focus on risk of bias
  • are developed by multidisciplinary teams
  • avoid use of summary numerical quality scores
  • incorporate domain specific or overall assessment of risk of bias.

The LATITUDES Network believes the library will benefit “anyone needing to assess the validity of their evidence base as part of an evidence synthesis”.

The library will benefit “anyone needing to assess the validity of their evidence base as part of an evidence synthesis”.

How to get started?

The LATITUDES Network provides a range of resources that can help researchers get to grips with validity tools — including guidance on which tool to use and training resources — or enable them to register a tool for inclusion.

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What do you think – will the resources provided by the LATITUDES Network improve the quality of validity assessment in evidence synthesis?

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2024 European Meeting of ISMPP https://thepublicationplan.com/2023/12/05/2024-european-meeting-of-ismpp/ https://thepublicationplan.com/2023/12/05/2024-european-meeting-of-ismpp/#respond Tue, 05 Dec 2023 10:37:59 +0000 https://thepublicationplan.com/?p=14936

The 2024 European Meeting of ISMPP is being held 23-24 January, at Novotel West in London.


REGISTER TODAY!
Registration is Open Until 9 January 2024


The 2024 theme of Innovation: The New Tradition ties the new innovations that have been introduced into our industry to the existing high standards, principles, processes and ethics that are entwined in the more traditional ideas. Sessions will explore how to incorporate innovation while maintaining the high standard of checks and balances that are already in place. The two-day programme is a must-attend to learn about the latest practices!

Plenary Sessions Include:

  • Innovation in Medical Communications and Publications Through Generative AI
  • Medcomms 2030: A Blue Sky & Black Cloud Perspective
  • The Perception of Pharma and the Role of Publications: One Step Forward or Two Steps Back?
  • Innovation Meets Tradition: The Future of Publication Extenders

Parallel Sessions Include:

  • Stakeholder Compensation for Services in the Evolving Publications Landscape
  • Making an Impact: What Does Success Look Like in Publications?
  • From Blue Sky to Bottom Line: Getting Innovation Off the Ground

Sprint Activities Include:

  • Reimagining the Publications Process to Make it 2030 Ready
  • Establishing Best Publication Practices for Pharma–Non-Pharma Collaboration
  • How Do We Strengthen the Position of Publications as a Trustworthy Source to All Audiences?

PLUS 16 Roundtable Topics to Discuss, Keynote Speaker, Member Research Posters/Oral Presentations, Exhibitors, Receptions, Networking, and more!

Company Team Discount/Elite Sponsorship for 10 Team Members or More! VIEW the meeting agenda. REGISTER TODAY! Learn about ISMPP at: www.ismpp.org

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