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FDA's Temple Discusses Measuring Efficacy When Mean Effect Is Limited

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The distribution of positive results for individual patients, as well as a drug's mean benefit across the population of treated patients in a clinical trial, can be useful in assessing efficacy, CDER Deputy Director for Clinical Science Bob Temple indicated March 2 during a meeting on clinical trials for pulmonary arterial hypertension
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