The randomized clinical trial is considered to be the most reliabletool to assess the efficacy and safety of new drugs. At times,however, randomized trials detect adverse events that are unanticipatedand not easily explained on the basis of current knowledge.An unexpected finding of this kind may ultimately prove to bedue to chance, but follow-up studies sometimes confirm the adversedrug effect. Particularly when an unexpected finding raisesa safety concern with regard to a drug, physicians face uncertaintyabout how to act on the 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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[Abstract]