FDA/CDER launch clinical data summary pilot program

On Tuesday, the US Food and Drug Administration and the Center for Drug Evaluation and Research (CDER) launched a new pilot program to evaluate whether disclosing certain information included within clinical study reports (CSRs) following approval of a New Drug Application (NDA) improves public access to drug approval information.

As part of this pilot, the agency intends to post the parts of the CSRs that were most important to the FDA’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 the 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.

The pilot will begin this month. It will ultimately include up to nine new drug applications across a range of disease areas. The FDA intends for initial participation in the pilot to reflect products that are novel and of scientific interest. Soon the FDA will begin contacting sponsors to see if they are interested in participating in the pilot. It will also continue to protect patient privacy, trade secret, and confidential commercial information in the CSRs released as part of the pilot. Once the clinical trial transparency pilot program is complete, we will seek public feedback through a Federal Register notice and docket for public comments.