Commentary: Professional responsibilities
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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 in publications of clinical trial results. Publications are extremely important, as they are the way by which the results of clinical trials are disseminated to the world at large. Publications may be used by clinicians as the basis for treatment decisions, and may also be used by meta-analysts in arriving at evidence-based recommen- dations. The consequences of inaccurate data in publications can therefore be extremely serious, as they could lead to poor treatment decisions, which in some cases could be fatal. The authors of these three papers are therefore to be congratulated 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 to manipulate the data. There is a widely held perception that the second of those is the greater risk in industry-sponsored studies, although the opposite may be true. Recent research has found that, when errors in papers are serious enough to warrant a retraction, the reason for the retraction is less likely to be misconduct in industry-sponsored studies than it is in indepen- dent studies [1]. Pyke et al. are therefore correct to question the assumption inherent in JAMA’s policy of requiring independent reanalysis only of industry-sponsored studies, namely that industry-sponsored studies are somehow less trustworthy than independent studies. Nonetheless, as Pyke et al. also acknowledge, there is no room to be complacent about the quality of clinical trial publications. There are undoubtedly many publications of poor quality, both from within and out with the industry, and statisticians have an important role to play in improving publication quality. This initiative by this group of statisticians nicely complements an initiative that I was involved in a few years ago as president of the European Medical Writers Association. Medical writers are also intimately involved in publications for the pharmaceutical industry, and we in EMWA published guidelines designed to improve the ethical standard of publications written by professional medical writers [2]. There is some evidence that this has started to bear fruit, at least as it affects ‘ghostwriting,’ the practice of failing to disclose that a medical writer has assisted with writing an article. Since the publication of the guidelines, the role of medical writers is more likely to be openly declared in the acknowledgement section of a paper than it used to be, although there is still a way to go before transparency and acknowledgement is universal [3]. Our guidelines do not have a narrow focus on ghostwriting, but also emphasize the wider professional responsibilities of medical writers. The professional responsibilities of statisticians in ensuring the quality of publications of clinical trial results are arguably greater than those of medical writers. The statistical aspects of a clinical trial paper are often crucial for the overall interpretation, so the statistician has an important role in ensuring that they are accurately described. One important aspect of that accurate description is to ensure that the status of objectives in the publication matches that in the protocol, for example that secondary objectives are not magically promoted to the status of primary objectives when the true primary objectives turn out to be disappointing. The frequency of published objectives not matching pre-specified objectives is worryingly high [4], and although there is no reason to believe that this mismatch is any more prevalent in industry- sponsored trials than in independent trials, industry statisticians nonetheless have an important duty to remain vigilant in guarding against it. Matcham et al.’s recommendation that protocols should be made publically available is therefore welcome, as it provides a useful safeguard against flipping of objective priorities. Another welcome recommendation is that statisticians should be authors of papers. Gøtzsche et al. investigated the authorship status of statisticians, and found that statisticians were frequently not authors of papers [5], although doubtless in many of the cases they investigated the statistician would have fulfilled generally accepted criteria for authorship. Being an author of a paper should emphasize the important point that the statistician must take professional responsibility for the scientific accuracy of the paper. Taking that professional responsibility seriously is undoubtedly an important step towards more reliable publications. Adam Jacobs Dianthus Medical Limited, London, UK References [1] Woolley KL et al. Round up the usual suspects? Involvement of medical writers and the pharmaceutical industry in retracted publications. Abstract presented at the Sixth International Congress on Peer Review and Biomedical Publication, Vancouver, September 2009. [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 a 2008 vs 2005 survey of medical writers. The Write Stuff (Journal of the European Medical Writers Association) 2009; 18:118–123. [4] Mathieu S et al. Comparison of registered and published primary outcomes in randomized controlled trials. Journal of the American Medical Association 2009; 302:977–984. [5] Gøtzsche PC et al. Ghost authorship in industry-initiated randomised trials. PLoS Medicine 4(1): e19. DOI: 10.1371/journal.pmed.0040019. 82 COMMENTARY (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.
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Transcript of Commentary: Professional responsibilities
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.
82
COMMENTARY
(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.
