FDA regs and clinical trials

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On September 27, 2007, President Bush signed into law the Food and Drug Administration Revitalization Act. The New England Journal of Medicine (NEJM) reports on the parts of the legislation that they see as most relevant to their readership. They are asking patients to consider only studies whose sponsors have fully registered them in an appropriate public database and agreed to publish their results.

From the article:

Of special interest to us, an additional provision of the act requires sponsors of all clinically directive therapeutic trials to register their studies, at inception, in a public database sponsored by the National Library of Medicine. Although some aspects of this provision are not ideal, such as the delayed public availability of registration information on device trials and the noninclusion of phase 1 trials, mandatory registration represents a critical advance in making clinical trials of new treatments public knowledge. In this regard, the act is in accord with the position of the 12 general medical journals that form the International Committee of Medical Journal Editors,2,3 which have since 2005 required that trials be registered before they can be considered for publication, and the World Health Organization’s International Clinical Trials Registry Platform.4

A decade ago a clinical trial could be conducted in secret. The trial’s sponsor, claiming proprietary rights, could keep all information about it, including its very existence, private. Thus, if a drug had important adverse effects, this information might never be made public. Legislators believed that such a possibility was not in the best interests of the American people. Once a clinical trial is mounted, the sponsor has an ethical obligation to publicly acknowledge the contribution of the participants and the risk they have taken by ensuring that information about the conduct of the trial and its principal results are in the public domain.4 With the FDA Revitalization Act, the United States joins other countries in recognizing that the human volunteers needed to complete a trial are more precious than the money required to mount it. Between study subjects and financial sponsors, it is easy to see who is taking the greater risk.

It is time for participants in clinical trials to take the initiative. People interested in participating in trials should consider only studies whose sponsors have fully registered them in an appropriate public database and agreed to publish their results. All of the required fields in a trial registry must be completed. Entries that obscure a trial’s intent subvert a fundamental purpose of trial registration. We trust that database managers will not allow this to occur.

To read the article in NEJM click here.

By | 2017-10-19T10:59:15+00:00 October 5th, 2007|Tools for Activists, Treatment News|0 Comments

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