FDA Concludes the Clinical Data Summary Pilot Program
The FDA has called a halt to its Clinical Data Summary (CDS) pilot program after two years and limited results, saying it will shift its focus to a new application review process that would allow more transparency and access to data from trials of approved drugs.
The agency launched the voluntary CDS pilot in January 2018 to evaluate whether sharing data from FDA-approved drugs’ clinical study reports would be beneficial to sponsors, researchers and the public. After selecting nine sponsors to participate in the pilot, the agency was able to release data from only one approved drug — Janssen’s Erleada (apalutamide) — in March 2018.
Then in June 2019, the FDA announced it was closing enrollment in the pilot and beginning work on the interdisciplinary review program, which the agency says has more potential for data-sharing by involving more parties in the evaluation of drug applications rather than releasing sponsor’s trial summaries. Center for Drug Evaluation and Research Director Janet Woodcock said last week, however, that the FDA may consider sharing specific portions of clinical data summaries as part of the new review process.
Despite its limited success, the FDA says the CDS pilot has helped the agency identify possible approaches to global sharing of clinical trial data, including an independently run international library of data that would allow sponsors to contribute results voluntarily in an anonymous and standardized format.