Clinical Data Summary Pilot Program

The Center for Drug Evaluation and Research (CDER) is committed to improving efficiency and transparency in the drug approval process. Consistent with this goal, in 2018 CDER launched a pilot program 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. The pilot program was open to up to nine new drug applications (NDAs). CDER planned to release portions of the clinical study reports (CSRs) from the sponsor’s NDA along with the action package following approval. The CSRs are made up of summaries of clinical information used in making market approval decisions, and were included in the information posted at the drug’s entry at Drugs@FDA.

CDER’s goal was to provide a usable summary of clinical evidence. During the pilot FDA gathered feedback about how useful posting portions of CSRs of the summary data in this format might be for the drug research and development community, medical researchers, and the public.

Clinical Study Reports

Erleada

Update [03/26/2020]

After receiving very useful, internal and external, knowledge and feedback as part of the pilot program, FDA has decided to conclude the pilot. Although the pilot is ending, given the interest in increasing transparency in the drug approval process, the agency has gathered many lessons learned that we will apply to future efforts. For example, the agency found that there are significant inefficiencies in having multiregional disclosure requirements relating to often identical clinical data summaries. These inefficiencies multiply the transactional, administrative, and redaction (because there are differing regional disclosure standards) costs, whether the costs are incurred by industry or the regional regulatory authority. These costs create barriers to programs to disclose clinical trial information which might be reduced if a multiregional/centralized or regional approach could be achieved.

Through the pilot, the agency also identified a potential approach that could facilitate a harmonized system for disclosing study reports, if legal and regulatory barriers could be removed. The general framework of this approach can be found in this FDA Statement.

Update [6/26/2019]

The recruitment phase of the pilot has now concluded. Throughout this process, FDA has gathered valuable information and remains committed to providing a usable summary of clinical evidence. As we move into our evaluation phase, FDA has published a federal register notice seeking feedback on the pilot.

We are also gathering feedback on another effort that also seeks to provide greater clarity on FDA’s application review and decision-making process. This new integrated review process and template developed under the New Drugs Regulatory Program Modernization, which is part of a multi-year, multi-phase effort to enhance the new drugs regulatory program, are intended to promote more integrated and interdisciplinary assessments, enhance clarity of our assessments regarding the benefits and risks for new drug products, and improve our communication about the basis for new drug approvals. FDA believes this program will also meet the goal of effectively communicating the basis for new drug approvals. The Agency is therefore considering whether to focus its efforts to better communicate the basis for drug approvals on the development of new integrated review documents, rather than on the release of CSRs. The Agency looks forward to stakeholders’ thoughts about these programs so that we can continue to provide information that is clear and transparent.

U.S. Food and Drug Administration

Clinical Data Summary Pilot Program

Clinical Study Reports

Additional Information

Clinical Study Reports

Additional Information

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