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 recommendations. 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 independent 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 industrysponsored 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.