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