Composite endpoints and the distortion of risk–benefit analysis

Br J Clin Pharmacol

17 January 2017 - Evidence-based medicine is a reassuring phrase, but when we prescribe has the evidence for safety and efficacy been treated fairly? Composite endpoints are a problem in this respect. 

They are used extensively in clinical trials to detect efficacy, yet used rarely to detect safety signals. Composite primary endpoints can find signals that might otherwise go undetected and when restricted to one side of the equation may distort the risk–benefit analysis. Their use influences many areas, including the current debate on statins and most of psychopharmacology.

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Michael Wonder

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Michael Wonder