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The agency’s Clinical Data Summary Pilot program will post redacted Clinical Study Reports in order to help stakeholders understand why FDA approved a new drug application.
FDA hopes its new pilot program, the Clinical Data Summary Pilot, will help to enhance future drug development by sharing portions of clinical study reports (CSRs), according to Janet Woodcock, MD, director of the Center for Drug Evaluation and Research, in a FDAVoice blog post. The agency’s goal is to directly share complete summaries of clinical trial information evaluated during FDA review of new drug applications (NDAs) in order to explain “why” an NDA was approved.
According to FDA, providing CSRs may enhance the accuracy of information used in scientific publications, increase stakeholders’ understanding of FDA decisions, and inform healthcare providers about the results and regulatory decisions involved in NDA approvals.
“Often there is no complete description of the important efficacy trials, including the trial protocols, descriptions of any modifications made during the trial itself, and an explanation of all of the results … we will post key portions of the Clinical Study Reports (CSRs)-documents that sponsors create for FDA on each of their clinical studies. These portions would contain complete summaries of the study results, the protocol and protocol amendments, and the statistical plan,” Woodcock stated.
CSRs from up to nine approved NDAs will be posted during the pilot project. Confidential commercial information, trade secrets, and personal privacy information will be redacted from the released CSRs and patient-level data will not be released. FDA will seek public comment on the project in the Federal Register to determine how the information was accessed and used.