The 8^th European Medical Writers Association (EMWA) symposium, entitled ‘Research Integrity & The Medical Communicator: What We Do When No One Is Watching’ took place on 6^th November. Researchers, journal publishers and representatives from the pharmaceutical industry and medical communication agencies joined together in this virtual event, to share their perspectives on the importance of research integrity and how it can be achieved.

A summary of session 3 of the meeting is provided below to benefit those who were unable to attend, and as a timely reminder of the key topics for those who did.

Read our summaries of session 1 and session 2 of the meeting.

Session 3: putting it all into practice

Does science self-correct? What we’ve learnt at Retraction Watch

Ivan Oransky (Retraction Watch) opened the final session with an account of what has been learned over a decade at Retraction Watch.

The number of retractions has increased from around 40 per year in 2000 to 1,500 per year currently (excluding conference papers), although the rate may be levelling off. Retraction Watch had counted 38 retractions/withdrawals of COVID-19-related papers/preprints at the time of the talk. However, Oransky emphasised that we don’t know whether this is ‘a lot’ or not, as the denominator is unknown.

Common reasons for retractions, which on average take around 3 years from publication, are:

• duplication (‘self-plagiarism’)
• plagiarism
• image manipulation – particularly related to Western blots and prominently investigated by Elisabeth Bik
• faked data – such as the case of Scott Reuben, the original story broken by Retraction Watch’s co-founder
• fake peer reviews – by faking email addresses and systems, a researcher could review their own work; however, Oransky believes that updated systems mean that anyone attempting this now would probably be caught
• publisher error – for example, a retraction made if the same article is accidentally published twice
• authorship issues – guest authorship and ghost authorship do not account for as many retractions as we might imagine, and undisclosed conflict of interest information is often addressed via a correction rather than retraction
• legal reasons – legal routes may be pursued to try to get papers retracted, which may be linked to criticism being treated as defamation by some
• not reproducible – a minor, but controversial, reason for retractions; Oransky queries whether a paper should be marked in some way if this is the case, rather than being retracted.

Around two-thirds of retractions are due to research misconduct or scientific fraud, while honest error accounts for about 20% of retractions.

It was noted that peer review processes are missing a lot of errors, and in some cases journals have failed to respond to allegations. Oransky explained that, in his opinion, there is not a problem with peer review not catching everything – but he does object to publishers viewing the process as the gold standard when major issues are being missed.

A major issue for Oransky is that retracted papers are still cited as if they were never retracted, which may be unsurprising given that some journals do not indicate that a paper has been retracted. Retraction Watch has been working on solutions, and has partnered with Zotero so that users can receive alerts if publications in their database are retracted.

Oransky’s talk concluded on a positive note, highlighting several signs of change:

• increasing post-publication peer review, such as through PubPeer and data whistleblowers
• journals hiring research integrity specialists to identify issues that peer reviewers miss
• researchers taking action to retract their own papers.

The Q&A following Oransky’s talk also highlighted some important points:

• If a retraction notice is clear that the retraction is due to honest error, the author doesn’t suffer a citation penalty afterwards, so this shouldn’t discourage authors from doing the right thing – however, unclear notices or those specifying scientific fraud do lead to citation penalties for researchers.
• The vast majority of retractions originate from academic institutions that aren’t linked with pharma funding – however, this is unsurprising due to the different levels of scrutiny in academia and pharma; Oransky believes that using retractions as a metric for honesty or truth-telling would be problematic.
• Publishers can improve the situation by ensuring that retractions are clear and widely communicated, hiring research integrity managers, and participating in changing the incentive structures that might encourage retracted papers to be submitted in the first place.

Guarding the gates of the research integrity underworld: the medical writer as Cerebus

Art Gertel (MedSciComm, LLC) presented the final talk of the symposium, looking at the role of medical writers (whether in clinical research, regulatory or publications spaces) as guardians at the gates of research integrity.

Like a less fearsome version of the mythical Cerberus, the role of the medical writer is not monolithic but spans varied roles and responsibilities depending on the context. Like the 3 heads of Cerberus, the medical writer has responsibilities spanning 3 key areas:

• knowledge about science, medicine and regulatory affairs, used to ensure conformance with accepted standards and precedent
• process expertise, used to ensure quality, educate team members about standards, regulations and guidelines (and the consequences of not following them), establish expectations and project manage
• distillation and communication – to regulatory authorities, the scientific community or the general public – which may also involve education, establishing expectations and project management.

In their essential role as guardian of best practice, the medical writer must navigate this continuum to get the data through the labyrinth. The earlier the input from the medical writer, the greater the protection of the whole process from challenges to research integrity, whether at research and development stages or communication stages.

Gertel highlighted that the urgency and pressure to publish is particularly strong during the COVID-19 pandemic, which presents its own hazards. He feels that there is a dangerous trend towards ‘publication via press release’ (the release of data that has not been fully vetted, verified and adjudicated through peer review). The crisis has ‘pressure-tested’ the system, making long-overlooked vulnerabilities visible. Pressure has arisen from different directions, such as from the Trump administration seeking to expedite the availability of interventions for COVID-19, which Gertel believes could undermine the credibility of the FDA as the guardian of health and safety.

Gertel notes that we live in a world of standards, with a significant number of guidelines that must be navigated by medical writers, but help to direct the ethical, accurate, complete and transparent reporting of research, that boosts public trust. Among other guidelines, the AMWA–EMWA–ISMPP Joint Position Statement on the role of Professional Medical Writers makes the responsibilities and accountability of medical writers clear.

Another challenge is the varied terminology used in different companies, so ensuring common understanding of definitions (such as through using the CDISC Glossary) and avoiding ‘insider’ terms is key. Plain language summaries are also increasingly important.

In closing, Gertel noted that medical writers need to:

• be informed to counter misinformed authors
• be educated as to their roles as ‘reminders’ and ‘minders’
• be empowered to hold their team accountable and to comply with best practices, although this may not be easy depending on the status of the medical writer within an organisation
• serve in their varied roles beyond being the creator of a document.

Panel discussion: research integrity – how we can work together to strengthen it

Gertel proceeded to moderate the final panel discussion of the day. Key points included:

• Predatory journals were perceived as one of the biggest threats to research integrity as they damage the foundation of trust around medical publications. The role of medial writers in guiding authors to select reputable journals was highlighted, and attendees were directed to the AMWA–EMWA–ISMPP Joint Position Statement on Predatory Publishing. There was a call for further guidance around whether publications in predatory journals should be excluded from dossiers, or included with caveats.
• There is still a lack of diversity in clinical trials and publications – bringing in patient-authors and a diversity of perspectives (across different races, ethnicities and socio-economic demographics) throughout the process would be valuable.
• Moving at ‘warp speed’ for COVID-19 research is not appropriate – we must move at the speed of science to ensure research integrity and maintain data integrity standards to avoid undue harm.

Summary and conclusions

In closing the symposium, Martin Delahunty (InspiringSTEM Network) briefly summarised some key take-home messages from the day:

• Cultural change is required, underpinned by the principles of trust, transparency and open research.
• Continuous training and upskilling of medical writers is required to address the practical challenges of maintaining research integrity.
• A lack of diversity in clinical trials is still an issue that needs to be addressed.
• ‘Connectors’ such as Retraction Watch, Vivli and the United Kingdom Reproducibility Network can help us build better connections and increase interoperability.
• There is an opportunity to ensure that data sharing is not just required but incentivised to promote compliance.
• Reasons for retraction vary widely – error is human and researchers should admit to errors to correct the scientific record; however, publishers must do more to move retractions forward as these take far too long.
• Ensuring consistency and standards of peer review remains problematic and should be addressed by all stakeholders working togther.
• Despite the pressures to effect change quickly, we should only work at the ‘speed of science’.

Chris Winchester (Oxford PharmaGenesis) closed the meeting with his thanks to all participants, organisers and sponsors.

Call to action!

Based on the discussions throughout the meeting, it is clear that medical writers can play an important role in helping to strengthen integrity within medical communications if they:

• continue to encourage authors and clients to publish all studies, even those with disappointing or negative results
• ensure that authors are educated on predatory journals and choose only reputable peer reviewed journals
• avoid citing articles published in predatory journals
• advocate for the high standards of pharmaceutical company publication processes, and be willing to share best practice with academics, charities, non-government organisations and governmental funders
• avoid using impact factors when rating journals or researchers
• encourage clients and authors to register observational studies in an appropriate registry
• flag suspected misconduct in published research to publisher research integrity groups
• encourage clients and authors to publish research in a way that is accessible to all (open access to the full publication, with associated publication plain language summary)
• include ICMJE-compliant data sharing statements in peer reviewed publications
• check references lists and flag any retracted articles to the authors
• take pride in our work and uphold high standards of research integrity.

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Written as part of a Media Partnership between EMWA and The Publication Plan, by Caroline Greenwood BSc and Beatrice Tyrrell DPhil from 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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With thanks to our sponsor, Aspire Scientific Ltd

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