Patient population phenotyping prior to clinical trials may improve drug development, CDER seminar told.
Executive Summary
PATIENT POPULATION PHENOTYPING PRIOR TO CLINICAL TRIALS is one method for improving drug development, Robert Rubin, MD, Harvard/MIT Division of Health Sciences and Technology, told a Jan. 8 Center for Drug Evaluation & Research staff seminar. "The cornerstone of successful drug development is how well you characterize the patient prior to study entry and determine how well the patient fits carefully designed study entry criteria," he said.