KEY TAKEAWAYS

• US government executive orders targeting EDI programmes are prompting federally funded journals to censor demographic data and equity-focused language.
• Authors and editors are pushing back to ensure data are made available and to maintain the integrity of the scientific record.

Following US government executive orders to end federal equity, diversity, and inclusion (EDI) programmes and to only recognise two sexes, The BMJ has emphasised the importance of retaining sex and gender data in published research. In an article in Undark, Peter Andrey Smith highlights another example of the scientific community pushing back against federal pressure to remove EDI-related data.

Authors make a stand

Smith describes the case of anthropologist Tamar Antin and co-authors, who faced an unusual request from the federally funded journal Public Health Reports following acceptance of their paper on tobacco use. The editors requested removal of the word “equitably” and demographic data, citing compliance with executive orders. Rather than grant the request, Antin and co-authors withdrew their paper entirely and went public. This “act of defiance” was met with widespread support from the scientific community, who argued that removing demographic data doesn’t just affect one paper’s conclusions – it hampers future studies by denying other scientists the opportunity to reanalyse findings or build on existing research.

“Removing demographic data doesn’t just affect one paper’s conclusions – it hampers future studies by denying other scientists the opportunity to reanalyse findings or build on existing research.”

The bigger picture

Smith also shares examples of federally funded researchers requesting:

• withdrawal
• removal of authors from bylines
• specific wording changes

to accepted papers, citing the political landscape. While this affects a minority of submissions directly, maintaining the integrity of the scientific record is paramount.

Looking ahead, the Committee on Publication Ethics’ position statement emphasises that publishing decisions and language choices should not be influenced by politics or government policies, and there is no place for retractions to censor the scientific record.

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KEY TAKEAWAYS

• Legitimate open access and predatory journals are being conflated by some established actors, attempting to preserve legacy publishing.
• Understanding how to identify a true predatory journal is essential to maintaining scientific integrity.

With the rise in open access publishing, the presence of predatory journals has become a notable issue. However, in a Research Information article, Professor Emmanuel Andrès addresses labelling of legitimate open access journals as predatory by some in the publishing ecosystem.

Many accused journals have robust editorial standards and are indexed in respected databases like PubMed and DOAJ. So, why are they regarded as predatory? Prof. Andrès describes how some established actors have weaponised the term ‘predatory’ to exclude newcomers and protect the monopoly of legacy journals.

Open access versus exclusivity

Open access publishing can be affordable, accessible, and quick, enabling a broader range of individuals to publish, including those:

• new to research
• from non-elite universities or under-funded institutions
• from under-represented regions.

Historically, only a select few had the means to publish, largely due to the costs associated with legacy journals. Some may consider open access to result in a loss of publishing prestige. Prof. Andrès highlights that some established actors are terming any open access journal ‘predatory’ as a “convenient label” to dismiss them, in an attempt to preserve publishing exclusivity. On the contrary, Prof. Andrès says questioning the legitimacy of “all open access, fast-review, digitally native journals…is an intellectual laziness we can no longer afford”.

“Some established actors are terming any open access journal ‘predatory’ as a ‘convenient label’ to dismiss them, in an attempt to preserve publishing exclusivity”

Where can we draw the line?

Prof. Andrès notes that true predatory journals remain a significant threat to academic publishing. To help detect them, Prof. Andrès highlights 6 key characteristics to look out for:

• no transparent fee structure
• no visible or citable articles that can be corrected when necessary
• no clear peer review and editorial policies
• not indexed in recognised databases
• not a member of COPE
• not aligned with the Think.Check.Submit checklist.

While ‘predatory’ warns the research community of fraudulent journals, terming any journal that challenges traditional publishing  as such can be just as damaging. Before dismissing an open access journal branded as predatory, Prof. Andrès urges us to consider: is this truly fraudulent or is it just an outsider?

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KEY TAKEAWAY

• More than 100 institutions have declared their support for eLife’s reviewed preprint model, following the journal’s loss of impact factor.

Rather than only accepting papers recommended for publication by peer reviewers, eLife publishes all reviewed research as reviewed preprints. However, Clarivate, the provider of Web of Science, only indexes peer reviewed content, resulting in the loss of eLife’s impact factor for 2025. Rather than changing their publishing model, eLife agreed to be partially indexed in Web of Science’s Emerging Sources Citation Index (ESCI). But how has this been received?

As reported in Research Information, eLife surveyed over 100 institutions and funders to assess how their publishing model is viewed. Over 95% of respondents endorsed non-traditional publishing approaches like eLife’s, confirming publications will continue to be factored into hiring, promotion, and funding decisions.

Promoting integrity or outdated metrics?

Dr Nandita Quaderi, Senior Vice President and Editor-in-Chief of the Web of Science at Clarivate, stressed that policies must be applied universally to protect research integrity. Quaderi warned that “cover-to-cover indexing of journals in which publication is decoupled from validation by peer review risks allowing untrustworthy actors to benefit from publishing poor quality content”.

On the other hand, Ashley Farley, Senior Officer of Knowledge & Research Services at the Gates Foundation, believes Web of Science’s policy “reinforces outdated publishing metrics that hinder innovation”, while Damian Pattinson, Executive Director at eLife, noted that with increasing emphasis on open science, “eLife remains confident that its model represents the future of scholarly publishing – one that prioritises scientific quality, transparency, and integrity over outdated prestige metrics”.

“eLife remains confident that its model represents the future of scholarly publishing – one that prioritises scientific quality, transparency, and integrity over outdated prestige metrics.”
– Damian Pattinson, eLife

As debates over the future of the impact factor continue, Farley believes that “indexers must evolve to support responsible, transparent models like eLife’s”.

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KEY TAKEAWAYS 

• The International Association of Scientific, Technical & Medical Publishers’ Research Identity Verification Framework aims to tackle fraudulent submissions, including from paper mills.
• The framework of layered identity checks for researchers, peer reviewers, and editors aims to raise obstacles to misconduct and enhance transparency, while maintaining inclusivity for all authentic researchers.

Research is facing an unprecedented integrity challenge, with sophisticated paper mills publishing poor-quality and fraudulent papers by unverifiable researchers and fake personas. To combat this issue, the International Association of Scientific, Technical & Medical Publishers (STM) has developed a Research Identity Verification Framework, released for community review. In an interview with Retraction Watch, Hylke Koers, Chief Information Officer at STM, shared how the framework could be used by journals and institutions to verify the identity of researchers.

Why is the framework needed?

Currently, publishers rely on time-consuming manual checks to validate the identity of contributors such as authors, peer reviewers, or guest editors. These processes do not match the speed and organisation of fraudulent networks. Part of the problem lies in the ease with which untraceable digital identities can be created and used to manipulate key parts of the publishing pipeline, for example, suggesting a fake reviewer. New approaches are needed to tackle this growing issue.

How will the framework be used?

The framework introduces a layered, systemic method of identity verification. Suggested methods include asking individuals to:

• validate an institutional email address
• sign in via ORCiD or use ORCiD Trust Markers
• provide a government document, such a passport or driving licence.

Koers notes that implementing these checks would make impersonation or identity theft more difficult and improve accountability, while multiple options for verification retain accessibility. Publishers are advised to assess the level of risk, asking “how confident can we be that this person is who they claim to be, and that the information they’ve provided is genuine?”.

“Implementing these checks would make impersonation or identity theft more difficult and improve accountability”

What are the next steps?

The success of the Research Identity Verification Framework will rely on widespread adoption. The STM plans to collaborate with early adopters to develop practical implementation pathways and refine future recommendations.

Koers notes that ultimately, no framework can eliminate all fraud, but making it more difficult to act fraudulently and easier to trace and respond to publishing misconduct should have a positive impact.

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KEY TAKEAWAYS

• Scientific image editing serves a vital role in clear communication, but seeking presentation clarity must not compromise data integrity.
• Combatting image manipulation requires systematic collaboration across the research ecosystem, including standardised guidelines and new verification technologies.

As concerns mount over image manipulation in scientific publishing, the research community has begun developing new strategies to balance visual clarity with data integrity. Writing in Nature, Sara Reardon explores the “fine line between clarifying and manipulating”, highlighting the challenge of making figures both accessible and faithful to original data.

The art and science of visual presentation

Scientific images often require editing for clarity, like adjusting brightness, adding scale bars, or enhancing contrast. While such modifications are essential for effective scientific communication, a 2021 study by Helena Jambor and colleagues revealed that poorly presented figures remain surprisingly common, suggesting researchers need better training in visual data presentation.

When enhancement becomes manipulation

The boundary between legitimate clarification and misconduct can be perilously thin. Science integrity consultant Elisabeth Bik warns that even minor edits – such as cloning image sections to cover dust particles – can undermine data credibility. Echoing a seminal 2004 article, Bik emphasises that “the images are the data”, meaning they should present the results actually observed rather than those the researchers expected. Any undisclosed alteration that changes the scientific message could constitute misconduct. As Reardon notes, the cardinal rule remains to “show your work” – enhancing clarity without obscuring underlying data.

“The boundary between legitimate clarification and misconduct can be perilously thin… the cardinal rule remains to ‘show your work’ – enhancing clarity without obscuring underlying data.”

Detection and prevention strategies

Phill Jones examines potential systemic solutions to what Bik calls science’s “nasty Photoshop problem” in The Scholarly Kitchen. Journals increasingly conduct pre-publication screening using image-integrity specialists or AI tools that have demonstrated substantial promise in identifying manipulated images. Guidelines such as those from the International Association of Scientific, Technical & Medical Publishers aim to standardise best practice, while individual journals are also establishing specific image integrity requirements. Beyond journals:

• Institutions are urged to provide training and embed image integrity expectations into research culture.
• Post-publication peer-review platforms also play a role in identifying problematic images after publication.

Looking ahead, technical innovations offer promise. Jones highlights developments such as encrypted hashes and digital ‘signatures’ embedded in images, akin to secure web certificates, that could enable reliable verification of image authenticity. Ongoing collaboration and systematic change across the research ecosystem will be required to ensure scientific images are both clear and credible.

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The 2025 ISMPP Academy takes place on November 13-14 in Boston.

REGISTER TODAY!
Registration is open until October 30, 2025

ISMPP’s 2-day interactive educational academy provides real-world solutions and focuses on implementation across four critical areas: Future of Work (AI), Compliance and Clarity, Operational Success, and Communication Impact. View the full agenda online!

Topics covered include:

• Publication planning
• Visual communications
• GPP and publication policies/SOPs
• Plain language summaries
• Real-world evidence
• Practical AI

 Academy features:

• 6 unique active learning sessions – for both newer professionals and experienced professionals
• Evaluate case studies
• Group problem-solving
• Certification: earn up to 10 CMPP credits
• Networking: two days of face-to-face professional connection
• Solutions: visit the Tabletop Exhibit Gallery showcasing medical communications and technology providers

PLUS Technology Demos, Exhibitors, Networking, and More!

VIEW the meeting agenda. REGISTER BY OCTOBER 30!
Learn about ISMPP at: www.ismpp.org

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KEY TAKEAWAYS

• Structured publication planning is no longer optional in MedTech—it’s a regulatory, clinical, and commercial imperative.
• Pharma-derived models need to be adapted to suit the realities of device, diagnostic, and software-based innovations.
• ISMPP offers cost-effective, flexible tools to upskill teams and foster peer learning—especially where internal capacity is limited.
•  Companies that commit to educating their staff on the foundations of publication planning can gain visibility, credibility, and strategic advantage.
• Partnering with publication professionals and/or agencies allows companies to implement strong publication practices now, while building internal knowledge and capacity for the future.

Introduction: MedTech at a crossroads

The medical technology (MedTech) sector is evolving rapidly, the result of both design innovations and increasing regulatory requirements. These dual trends have transformed nearly all areas of the industry, which spans surgical devices, diagnostics, digital health platforms, and increasingly, software and artificial intelligence (AI)-powered tools.

Yet there’s one area where MedTech appears to remain more static: publication practices. This isn’t due to any inherent limitations within the industry, but rather because most MedTech companies—especially small to mid-sized ones—simply lack the internal infrastructure to support strategic, consistent publication planning and execution.

As outlined in a previous article focused on small pharma and biotech companies, the International Society for Medical Publication Professionals (ISMPP) plays an essential role in equipping publication professionals with the tools and community they need to stay ahead. That same opportunity—and urgency—now applies to MedTech.

“There is growing recognition that MedTech products bring enormous value to healthcare, and with that has come increasing scrutiny. To keep pace, companies must apply the same innovative spirit to publication practices as they do to product development. Those that invest in building publication planning knowledge and resources now can set the standard for the field going forward.”
– John Watson, The Manuscript Agent

The publication planning gap in MedTech

Unlike the pharmaceutical sector, many MedTech companies don’t have dedicated publication teams. Instead, evidence dissemination responsibilities often fall to medical affairs or regulatory staff juggling multiple roles. Although at odds with good publication practice, and because of the unique MedTech environment, commercial roles are sometimes involved as well. As a result, publication efforts may be reactive—tied solely to product launches or regulatory milestones—and lack long-term strategic vision. When publication plans exist, they are often developed without input from all relevant stakeholders, potentially resulting in redundancies or even conflicting messages.

Adding to the complexity, traditional pharma-derived publication models don’t map neatly onto MedTech lifecycles. MedTech products tend to iterate faster, making it harder to generate long-term evidence. Whereas pharma hinges on large randomized controlled trials, MedTech evidence generation more often depends on an array of smaller studies, retrospective analyses, registries, and other pragmatic data sources that balance scientific rigor with cost constraints. These differences can be especially challenging for smaller companies with limited bandwidth for structured publication planning.

A survey conducted by the ISMPP Small Companies Education Committee found that professionals in small and device-focused companies cite lack of time, training, and structured guidance as top barriers to publication planning. (1)

Regulatory and market pressures are rising

Regulatory requirements facing the industry have intensified, particularly with the implementation of the European Medical Devices Regulation (EU MDR). Where companies were once able to rely on data with comparable devices, they now must provide robust clinical evidence with their own technologies. This shift has also increased scrutiny of post-market surveillance, safety reporting, and health economic data from regulators, payers, and clinicians.

Meanwhile, the MedTech industry is innovating at an accelerated pace. The number of FDA-cleared AI and machine learning-enabled devices surpassed 1,000 in 2024, with software-based tools leading the charge. These novel products raise complex new questions around algorithm transparency and evidence generation, placing further emphasis on the need for timely, well-structured publications.

In short, MedTech companies face an unprecedented imperative to generate and communicate high-quality data on their products. Just as they have innovated with their products, so too must they adopt strategies for successful evidence dissemination.

Whether launching a Class III implant or a Class I digital tool, companies must demonstrate credibility—and transparent, peer-reviewed publications remain the most effective way to do so. By strengthening their foundational knowledge around publication planning now, MedTech teams can do more than keep pace with change—they can lead it.

What MedTech can gain from stronger publication planning

Publication planning is not just about compliance; it’s a strategic investment in building credibility, commercial success, and trust. With even modest investments, MedTech companies can:

• ensure clinical evidence is disseminated through credible, peer-reviewed channels
• boost HCP confidence and product adoption
• build long-term visibility for products and platforms
• support regulatory and reimbursement submissions.

Better publication planning strengthens the story around a product and helps ensure that story is heard.

Building skills and capacity: how ISMPP can help

ISMPP offers education and training especially relevant to those navigating the complexity of MedTech communications. For companies without formal training programmes or clear internal publication processes, ISMPP serves as a practical partner and knowledge hub.

Members benefit from:

• training on Good Publications Practice (GPP 2022)
• guidance on authorship, transparency, and AI use in writing
• access to ISMPP U webinars, podcasts, and the CMPP certification
• peer connection via ISMPP Connect, which includes professionals working in diagnostics, devices, and software settings.

ISMPP’s Certified Medical Publication Professional (CMPP) credential is recognized globally and is increasingly valued by employers and partners in the MedTech sector.

Partnering with experts: agency support for publications

MedTech companies aren’t on this journey alone: many choose to partner with medical communications agencies who bring expertise, familiarity with compliant publication processes, and therapeutic area knowledge—without requiring additional internal hires.

This hybrid model works especially well when:

• teams are stretched thin
• publication needs must scale quickly
• expertise in regulatory-driven publication formats is lacking.

Strategic partnerships allow even smaller companies to produce high-quality, compliant publications that support key business objectives.

This article was developed on behalf of the ISMPP Small Companies Outreach Committee by John Watson (The Manuscript Agent), Tony Ferrar (Porterhouse Medical), and Anne-Clare Wadsworth (Amica Scientific). Please note, the authors used ChatGPT-4o (OpenAI) to support the collation of resources and to generate an initial outline and draft of the manuscript. The authors reviewed, edited, and take full responsibility for all subsequent content and the final submitted version.

References

(1) Carroll L, Duggan S, Sweetlove M, Gor V, Kelley D, Pinkham L, Piano CA. Identifying processes and challenges in medical publication planning and execution for small biopharmaceutical companies. Presented at: International Society for Medical Publication Professionals (ISMPP) Annual Meeting; 12–14 May 2025; Washington, DC

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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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KEY TAKEAWAYS

• Inclusive publishing recognises the value of all validated research in enhancing scientific reproducibility and progress.
• Publishers must embrace inclusive practices to reflect diversity within the scientific landscape.

Inclusive journals value null results, preliminary data, and experimental design papers, which promote reproducibility and can hasten innovation. Unlike selective journals, which prioritise ‘high impact’ discoveries, inclusive journals recognise that research does not need to be ground-breaking to be an advancement. In a Springer Nature article, Ritu Dhand discusses the benefits of inclusive publishing.

COVID-19: a case study

Dhand highlights how the COVID-19 crisis created an unprecedented need for peer-reviewed science. Journals responded by adopting inclusive publishing practices, recognising the importance of preliminary data and innovative methods. The rapid dissemination of pilot studies and null results enabled scientists worldwide to focus precious time and effort on pushing unexplored frontiers. Inclusive publishing proved pivotal in an extraordinary global effort to compress drug discovery timelines from years to months. However, these inclusive practices faded after the pandemic.

The price of selectivity

Dhand notes that 50% of research is unpublished. Rather than lacking scientific rigour, most rejections occur because journal editors consider the research to lack significance. A study prepared for the European Commission estimated that in 2018, €26 billion was wasted on duplicated research in Europe alone.

50% of funded research is unpublished. Rather than lacking scientific rigour, most rejections occur because journal editors consider the research to lack significance.

Value beyond citation metrics

Inclusive journals often publish a high number of papers, leading to lower impact factors. However, the value of the research can be measured by other metrics. For example, over a third of Springer Nature’s inclusive content addresses the UN Sustainable Development Goals, demonstrating its societal impact.

Diversity in research publication

Inclusive publication practices also involve increasing the diversity of authors and countries contributing research. Dhand highlights that a similar proportion of research publications are from Western Nations and Asia, yet editorial boards and reviewers remain Western dominated. As key decision makers, individuals in these roles should reflect the diversity of the research communities.

Dhand acknowledges that selective journals will continue to offer a platform for ground-breaking research, but highlights the need for widespread inclusive publication practices to satisfy the evolving needs of science and society.

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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.

2. Build a legacy

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

3. Elevate patient advocacy

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

4. 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.

5. 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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