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Previous Volume 360:824-830 February 19, 2009 Number 8 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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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 . . . [Full Text of this Article]

Registration Requirements

Results-Reporting Requirements

Clinical Trials Results Databases

The Need for Additional Legislation

Conclusions

Source Information

Dr. Wood is managing director of Symphony Capital and a Professor of Medicine and Pharmacology at Weill Medical College of Cornell University — both in New York.

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