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.
Source: FDA
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.