Commentary: Professional responsibilities

The three papers by Pyke et al., O’Kelly et al., and Matcham et al.address an important topic, namely the role of statisticians inpublications of clinical trial results. Publications are extremelyimportant, as they are the way by which the results of clinical trialsare disseminated to the world at large. Publications may be usedby clinicians as the basis for treatment decisions, and may also beused by meta-analysts in arriving at evidence-based recommen-dations. The consequences of inaccurate data in publications cantherefore be extremely serious, as they could lead to poortreatment decisions, which in some cases could be fatal.

The authors of these three papers are therefore to becongratulated for tackling what is an important and difficult issue.

There are two main ways in which papers can mislead:through incompetence and through deliberate attempts tomanipulate the data. There is a widely held perception that thesecond of those is the greater risk in industry-sponsored studies,although the opposite may be true. Recent research has foundthat, when errors in papers are serious enough to warrant aretraction, the reason for the retraction is less likely to bemisconduct in industry-sponsored studies than it is in indepen-dent studies [1]. Pyke et al. are therefore correct to question theassumption inherent in JAMA’s policy of requiring independentreanalysis only of industry-sponsored studies, namely thatindustry-sponsored studies are somehow less trustworthy thanindependent studies.

Nonetheless, as Pyke et al. also acknowledge, there is no roomto be complacent about the quality of clinical trial publications.There are undoubtedly many publications of poor quality, bothfrom within and out with the industry, and statisticians have animportant role to play in improving publication quality.

This initiative by this group of statisticians nicely complementsan initiative that I was involved in a few years ago as president ofthe European Medical Writers Association. Medical writers are alsointimately involved in publications for the pharmaceutical industry,and we in EMWA published guidelines designed to improve theethical standard of publications written by professional medicalwriters [2]. There is some evidence that this has started to bearfruit, at least as it affects ‘ghostwriting,’ the practice of failing todisclose that a medical writer has assisted with writing an article.Since the publication of the guidelines, the role of medical writersis more likely to be openly declared in the acknowledgementsection of a paper than it used to be, although there is still a way togo before transparency and acknowledgement is universal [3]. Ourguidelines do not have a narrow focus on ghostwriting, but alsoemphasize the wider professional responsibilities of medicalwriters.

The professional responsibilities of statisticians in ensuringthe quality of publications of clinical trial results are arguablygreater than those of medical writers. The statistical aspects of aclinical trial paper are often crucial for the overall interpretation,

so the statistician has an important role in ensuring that they areaccurately described.

One important aspect of that accurate description is to ensurethat the status of objectives in the publication matches that inthe protocol, for example that secondary objectives are notmagically promoted to the status of primary objectives whenthe true primary objectives turn out to be disappointing. Thefrequency of published objectives not matching pre-specifiedobjectives is worryingly high [4], and although there is no reasonto believe that this mismatch is any more prevalent in industry-sponsored trials than in independent trials, industry statisticiansnonetheless have an important duty to remain vigilant inguarding against it. Matcham et al.’s recommendation thatprotocols should be made publically available is thereforewelcome, as it provides a useful safeguard against flipping ofobjective priorities.

Another welcome recommendation is that statisticians shouldbe authors of papers. Gøtzsche et al. investigated the authorshipstatus of statisticians, and found that statisticians werefrequently not authors of papers [5], although doubtless inmany of the cases they investigated the statistician would havefulfilled generally accepted criteria for authorship. Being anauthor of a paper should emphasize the important point thatthe statistician must take professional responsibility for thescientific accuracy of the paper. Taking that professionalresponsibility seriously is undoubtedly an important steptowards more reliable publications.

Adam JacobsDianthus Medical Limited, London, UK

References

[1] Woolley KL et al. Round up the usual suspects? Involvement ofmedical writers and the pharmaceutical industry in retractedpublications. Abstract presented at the Sixth International Congresson Peer Review and Biomedical Publication, Vancouver, September2009.

[2] Jacobs A, Wager E. European Medical Writers Association (EMWA)guidelines on the role of medical writers in developing peer-reviewed publications. Current Medical Research and Opinion 2005;21(2):317–321.

[3] Jacobs A, Hamilton CW. Decreased evidence of ghostwriting in a2008 vs 2005 survey of medical writers. The Write Stuff (Journal ofthe European Medical Writers Association) 2009; 18:118–123.

[4] Mathieu S et al. Comparison of registered and published primaryoutcomes in randomized controlled trials. Journal of the AmericanMedical Association 2009; 302:977–984.

[5] Gøtzsche PC et al. Ghost authorship in industry-initiated randomisedtrials. PLoS Medicine 4(1): e19. DOI: 10.1371/journal.pmed.0040019.

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(wileyonlinelibrary.com) DOI: 10.1002/pst.428 Published online 16 April 2010 in Wiley Online Library

Pharmaceut. Statist. 2011, 10 82 Copyright r 2010 John Wiley & Sons, Ltd.