FDA Releases First Clinical Study Summary in New Transparency Pilot

The FDA issued the first clinical trial summary in its pilot program aimed at highlighting key information from pivotal trials of newly-approved drugs.

The goal of the new pilot is to assess whether flagging certain information included in Clinical Study Reports (CSRs) from the drug’s sponsor improves public understand of the agency’s reviews. The first summary is based on initial data from Janssen’s Erleada (apalutamide), indicated for patients with prostate cancer that has not spread.

Along with the sponsor’s full CSR, the agency includes complete summaries of study results, protocols and protocol amendments and statistical plans for all pivotal studies supporting the approval.