First Clinical Study Report Data Published for FDA Pilot Project

March 26, 2018

On Monday, March 19th, the FDA officially began a new Clinical Data Summary Pilot Program. This program is intended to “assess the feasibility of using a different format to provide required summaries of the safety and effectiveness information that is used to make regulatory decisions.”

Enhancing Transparency

In January, FDA Commissioner Scott Gottlieb, M.D., released a statement about the Agency’s efforts to increase transparency regarding drug approval decisions. As part of those efforts, the FDA announced a decision to launch a new transparency pilot program. As part of this program, the FDA will publish portions of certain clinical study reports (CSRs) from up to nine different new drug applications (NDAs).

According to the January statement, the FDA “Intend(s) for initial participation in the pilot to reflect products that are novel (including drugs that are new molecular entities, or NMEs) and of scientific interest (e.g., certain NDA efficacy supplements).” Sponsors who volunteer to participate in the pilot will receive additional information on the process, ensuring a thorough understanding of all procedures and expectations. In addition, the reports will be redacted to exclude personal patient information and trade secrets.

In a recent blog post from the FDA, Janet Woodcock, M.D. states that the portions of the CSRs to be released include:

  • Complete summaries of study results
  • Protocol and protocol amendments
  • Statistical plan

Initial Data

Although the pilot program was officially announced in January, study information from the first participant was not published until late March. The initial data for the pilot came from Janssen Biotech’s Erleada (apalutamide), the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer. The CSR of the pivotal study and the regular action package were published on the FDA’s website on March 19th.

Next Steps

The Clinical Data Summary Pilot Program is expected to include as many as nine different NDAs, meaning that up to eight more recently approved drugs may be part of the program. Once the pilot program is complete, the FDA will seek public feedback through a Federal Register notice.

Do you have an FDA-approved product on the market? Want to ensure you are in compliance with all of FDA’s rules and regulations regarding the marketing of your product? We can help. Contact us today to learn more about our services and how we can help you maintain compliance.



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