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FDA RESEARCH PROGRAM ON CLINICAL TRIAL METHODOLOGY AND ANALYSIS

This article was originally published in The Tan Sheet

Executive Summary

FDA RESEARCH PROGRAM ON CLINICAL TRIAL METHODOLOGY AND ANALYSIS was suggested by new FDA Center for Drug Evaluation & Research Director Janet Woodcock, MD, as a way of "mining" the "vast resource" of unpublished data and data analyses within the agency. In her first public address as CDER director, Woodcock told the Food & Drug Law Institute's Pharmaceutical '94 Update meeting in Washington, D.C. on May 23: "I feel there should be a research program within the FDA on clinical trial methodology and analysis." She also suggested that "some of the goals of these programs could be published and made publicly available."
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