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  1. Development & Approval Process | Drugs

Clinical Data Summary Pilot Program

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The Center for Drug Evaluation and Research (CDER) is committed to improving efficiency and transparency in the drug approval process. Consistent with this goal, CDER has 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 will include up to nine recently submitted new drug applications (NDAs). For these applications, if approved, CDER will 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 will be included in the information posted at the drug’s entry at Drugs@FDA.

CDER’s goal is to provide a usable summary of clinical evidence. FDA will gather 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. The Agency is also responding to stakeholders’ requests for improved access to usable information. It is FDA’s view that the information contained in the CSR sections that will be posted as part of the pilot is a summary, and FDA will not be posting raw data.  The portions of the CSRs that will be posted include information from the study report body, the protocol and amendments, and the statistical analysis plan for each study.

Soon after an approval, CDER will post the CSR sections below and in the relevant entry at Drugs@FDA.

Clinical Study Reports 

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.

Additional Information