An Open Letter in Response to the FDA ’s Public Comment Request on the Clinical Data Summary Report Pilot

This post was originally posted on the Cochrane Methods websiteIn January 2018, the FDAannounced a pilot aimed at enhancing the transparency of the Agency ' s drug approval process and decisions. As part of the pilot, sponsors of up to nine drug applications to the FDA were asked, on a voluntary basis, if they would approve the public release of portions of the CSRs, which would be posted within an Action Package for the drug that also includes FDA application review files and letters. The parts of the CSRs made publicly available included information from the study report body, the protocol and amendments, and the statistical analysis plan for each study.The FDA is calling for comments on this pilot as part of the ‘New Drugs Regulatory Program Modernization: Improving Approval Package Documentation and Communication’ call for public comment (deadline 26 August 2019).Karla Soares-Weiser, Editor-in-Chief of the Cochrane Library, and members of the Cochrane Clinical Study Report Working Group have submitted a response to this pilot, which is reproduced below as an open letter. The Cochrane Clinical Study Report Working Group is a recently announced, open group that aims to support and facilitate the increased use of CSRs in Cochrane Reviews.  The Clinical Study Report Working Group also invites, and welcomes, any sponsors or regulators who would like to reach out and initiate discussions with us to help facilitate CSR use in Cochrane Reviews. To date, only two published Co...
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