Gottlieb reveals pilot program for clinical data transparency

FDA Commissioner Scott Gottlieb said FDA launched a pilot program aimed at improving public access to clinical trial data for approved drugs. Gottlieb made the announcement at a symposium on FDA transparency held Tuesday at the Johns Hopkins Bloomberg School of Public Health.

Under the pilot program, FDA will disclose portions of clinical study reports from up to nine recently approved NDAs. Published data for an approved drug will include the study report body, protocol and amendments, and statistical analysis plan for each pivotal trial. Gottlieb said the drugs, including new molecular entities (NMEs), will be selected based on novelty and scientific interest. Data will appear on FDA's website under drug approval information as well as a new webpage...