Healthy Skepticism Library item: 15108

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Publication type: Journal Article

Wood AJJ.
Progress and Deficiencies in the Registration of Clinical Trials
The New England Journal of Medicine 2009 Feb 19; 360:(8):824-830
http://content.nejm.org/cgi/content/full/360/8/824?query=TOC

Abstract:

Clinical trials are essential to understanding the efficacy of medical interventions. The ethical underpinnings of this type of research involving human subjects, codified in the Belmont Report1 and the Declaration of Helsinki,2 require that the results be publicly available to inform medical practice as well as future research. In addition, basic principles of evidence-based practice require the analysis of all data on a given topic; the practice of publishing only some results, but not others,3,4 undermines our collective ability to make rational decisions about medical care.

In Section 801 of the Food and Drug Administration (FDA) Amendments Act,5 enacted in September 2007, Congress expanded the requirements for sponsors and investigators to post information about clinical trials, including selected aspects of trial results, on the U.S. government Web site ClinicalTrials.gov. These expanded requirements6,7 apply to all investigators and sponsors, whatever their source of funding. Section 801 also includes, for the first time, considerable penalties for noncompliance, including possible loss of grant monies from the National Institutes of Health (NIH) and civil monetary penalties of up to $10,000 per day. This mandate for registration and results reporting (Table 1) has important ethical, practical, and scientific implications for all who are involved in clinical research, as well as for all who rely on research results to guide their decisions on clinical care.