The open publishing of clinical trial data is a hot topic at the moment, but does everyone agree with the change? Tom Rees discusses. Research is the bedrock of the pharmaceutical industry. For new treatments to be adopted as part of medical practice, it is critically...
The open publishing of clinical trial data is a hot topic at the moment, but does everyone agree with the change? Tom Rees discusses. Research is the bedrock of the pharmaceutical industry. For new treatments to be adopted as part of medical practice, it is critically...

Tom Rees

PAREXEL International

Publishing clinical trial data is a fundamental part of communicating the science, but in this article, Tom Rees discusses the results of a recent survey which suggests that many doctors are sceptical.

Research is the bedrock of the pharmaceutical industry. For new treatments to be adopted as part of medical practice, it is critically important that the evidence from the clinical research programme is accessible to doctors and other healthcare professionals in a balanced and comprehensive manner. Indeed, in 2010, the International Federation of Pharmaceutical Manufacturers and &, Associations released their Joint position on the Publication of Clinical Trial Results, which commits all members to submit for publication the results from “all phase 3 clinical trials and any clinical trial results of significant medical importance”.

Publishing the results of a clinical trial is typically a collaborative effort involving the investigators, the lead clinical scientists from the sponsor, and a host of supporting players such as statisticians, clinical monitors, and often, medical writing professionals. As a result, deciding who is or is not an author on the publication from an industry-sponsored study can be a particularly challenging issue.

Past controversies over authorship have contributed to an atmosphere of suspicion among some doctors towards pharmaceutical company involvement in peer-reviewed publications. However, although there have been critical articles in both the scientific and lay press, the attitudes of ordinary healthcare professionals aren’t well understood.

In an Internet-based survey, 294 healthcare professionals around the world (mostly in the USA and Europe) were polled about their opinions on pharmaceutical company involvement in peer-reviewed publications and their knowledge of authorship criteria.

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Figure 1: The number of respondents concerned about pharma’s involvement in manuscript preparation

What we found was that two-thirds of respondents were concerned about the involvement of pharmaceutical employees in manuscript preparation, even if their involvement is disclosed. This varied by region, with northern Europeans showing the greatest concern, and North Americans the least (Figure 1).

In addition, nearly a third said that they would trust a peer-reviewed publication less if professional medical writers were involved in preparing the draft – although 14% would trust it more.

This is despite the fact that the individuals we surveyed were very open to collaboration with industry. We found that, among those who had previously been an author on a peer-reviewed publication (n = 204), 68% said that they would agree to be an author or co-author of a publication developed with the assistance of a professional medical writer. It seems that, although doctors are open to the idea of collaborating with the pharmaceutical industry, they are suspicious of others who do so – perhaps because the nature of the relationship is not always transparent.

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"… although doctors are open to the idea of collaborating with the pharmaceutical industry, they are suspicious of others who do so."

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Past controversies over authorship bylines have focussed on incomplete disclosure of individuals who have contributed to publications. I believe that much of the suspicion and concern could be removed by moving to a contributorship model, whereby all individuals involved in the development of the manuscript are listed, along with information on their specific contributions.

Currently, publications typically list only a small number of individuals who meet predefined criteria. The most widely-used criteria, developed by the International Committee of Medical Journal Editors (ICMJE), ask that all authors must have contributed substantially to the conception and design, acquisition of data, or analysis and interpretation of data. They must also have drafted the article or revised it critically for important intellectual content, and they should have approved the final approval of the version to be published.

However, we found that medical practitioners have only limited knowledge of these guidelines.

For example, while three-quarters of respondents agreed that designing the study or writing the paper are qualifications for authorship and two-thirds agreed that data analysis is, only half of the sample selected both these pivotal qualifications from a list of options. Even more seriously, a third of respondents thought that general supervision of the research laboratory is a qualification for authorship – something that is widely frowned upon.

Furthermore, we uncovered evidence of widespread incomplete or inaccurate disclosure of authorship. Among the 202 respondents who had ever authored a paper, 54% reported having co-authored a paper with a ‘guest’ author who did not merit authorship, while 70% reported working with ‘ghost’ authors (who merited authorship but were not named). Since these doctors have experienced incomplete disclosure in their own publications, it’s hardly surprising that they are suspicious of publications involving the industry!

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"...54% reported having co-authored a paper with a ‘guest’ author who did not merit authorship, while 70% reported working with ‘ghost’ authors…"

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“This latest study and other industry reports that EPG has conducted, indicate that while doctors recognise the importance of the pharmaceutical industry’s contribution to tools such as educational resources, CME, mobile apps and so on, they also expect a robust level of transparency,” said Michelle Kelly, Market Research Manager at EPG Health Media. “Blame and suspicion cannot be laid solely at pharma’s door. Appropriate models for ensuring full transparency are something that the wider industry needs to continue to strive towards if healthcare professionals are to trust the publications and tools that they consume as well as those involved in providing them.”

A contributorship model of authorship would resolve these problems by ensuring that all those who made a contribution were named and, more importantly, their role in the publication would be clear. This increased transparency would help to increase confidence in publications of industry-sponsored trials, by ensuring that the many people who contribute to a publication but who do not meet conventional authorship criteria are fully disclosed.

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About the author:

Tom Rees has worked in the Medical Communications industry for 16 years, with a focus on publications planning and delivery from a global perspective. In his role as Scientific Strategy Advisor, he has lead or facilitated the development of publication plans across several therapeutic areas (primarily cardiovascular, respiratory and psychiatric) involving co-ordination across multiple regions. His planning experience includes pre- and post-launch products, and across the life cycle – including strategic planning for challenges such as new indications and line extensions. He currently serves as a member of the ISMPP Global Workshop Committee.

You can contact Tom via email: tom.rees@parexel.com

The study mentioned in this article was designed by PAREXEL and conducted by EPG Health Media, publisher of www.epgonline.org, (the disease and medicines portal for healthcare professionals).

If you would like to know more about this research and its findings, you can access the full report on the EPG Health Media website here. PAREXEL also presented these data at the recent European meeting of the International Society for Medical Publication Professionals (ISMPP) in London, and the posters are available on their website – or by contacting the author.

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