FDA taking steps to enhance transparency of clinical trial information

FDA Commissioner Scott Gottlieb reports that as part of the agency's efforts to enhance transparency around its drug approval decisions, it is evaluating how to best release information that may better inform scientists, providers, and patients in clinical study reports (CSRs). FDA on Tuesday launched a new pilot program to evaluate whether disclosing certain information included within CSRs following approval of a new drug application (NDA) improves public access to drug approval information. FDA will select up to nine recently-approved NDAs whose sponsors volunteer to participate and post portions of clinical trial-related summaries from the pivotal trials that were submitted to the agency. FDA intends to post the parts of the CSRs that were most important to the agency's assessment of the safety and efficacy of the drug. Specifically, it will include the study report body, the protocol and amendments, and the statistical analysis plan for each of the participating product’s pivotal studies. The CSRs will be posted on a new web page on FDA's website that describes the pilot program, in addition to appearing on Drugs@FDA along with the drug’s approval information, soon after a drug is approved.