First, Gather the Data

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Abstract
It is a cornerstone of medical practice to “first, do no harm.” Yet the body of evidence that is sufficient to demonstrate efficacy for a new drug is rarely large enough to provide absolute assurance that harmful side effects do not exist. Thus, ongoing surveillance is necessary to detect adverse events.There are many reasons why the randomized trials that are adequate for demonstrating drug efficacy may not be adequate for the recognition of important side effects (see table). Randomized trials may be too small to permit the detection of adverse events. For instance, for a continuous outcome such as . . .

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