Publication Bias Against Negative Studies

Nature Clinical Practice Neurology includes an editorial on publication bias against negative results in clinical trials. The authors ask (and answer), “Who is to blame? Journal editors, commercial sponsors, and investigators (the would-be authors) all stand accused.”

There are plenty of reasons – good (well, understandable), bad, & ugly – that negative clinical trials are not published. The problem is that clinical researchers may unwittingly repeat unreported failed interventions, while reviews and meta-analyses of published data become increasingly skewed by such an imbalance in reporting. As reported in the New York Times, sometimes failed trials result in products not making it to or being removed from the market – often without notification of the patients enrolled in these negative studies.

Johnson & Dickersin conclude: “Bias against the reporting of negative results from clinical trials detracts from good patient care. There are a number of causes, in small part the pride of editors, ominously the avarice of corporate sponsors, and principally the negligence of investigators—to sustain the classical analogy to the cardinal sins one would need to use the unsavory word ‘sloth’. Evidence-based medicine relies fundamentally on weighing the pros and cons of different treatments fairly. The attention of journals, medical societies, government, business, institutional review boards, and clinical investigators is needed to balance the scales.”

Perhaps as the NIH looks to transform clinical and translational research, they could figure out a way to catalogue negative clinical trial data for the benefit of investigators and patients.

3 Comments »

  1. […] raised is the lack of respect for study volunteers who put themselves at risk for the greater good. Nonpublication of negative results is common and occurs for many reasons, but the possibility of COI cannot be ignored, particularly when […]

  2. […] commentary, Moving Toward Transparency of Clinical Trials, in which they discuss problems of reporting bias against negative trials and review Section 801 of the FDA Amendments Act (”FDAAA 801″), which was enacted on […]

  3. […] Previously, Richard Johnston and Kay Dickersin (both from Johns Hopkins) also raised the issue of publication bias against negative clinical trials in Nature Clinical Practice Neurology. […]

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