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Published at www.nejm.org September 2, 2008 (10.1056/NEJMe0807200)

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The randomized clinical trial is considered to be the most reliable tool to assess the efficacy and safety of new drugs. At times, however, randomized trials detect adverse events that are unanticipated and not easily explained on the basis of current knowledge. An unexpected finding of this kind may ultimately prove to be due to chance, but follow-up studies sometimes confirm the adverse drug effect. Particularly when an unexpected finding raises a safety concern with regard to a drug, physicians face uncertainty about how to act on the information.

In this issue of the Journal, we publish the results . . . [Full Text of this Article]

Source Information

This article (10.1056/NEJMe0807200) was published at www.nejm.org on September 2, 2008. It will appear in the September 25 issue of the Journal.

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