Updates on the Clinical Trial Transparency
FDA has announced its first participant in the Clinical Data Summary Pilot Program. In FDA’s 14 February press release announcing the approval of Janssen Pharmaceutical’s product Erleada, FDA noted “… The sponsor for Erleada is the first participant in the FDA’s recently-announced Clinical Data Summary Pilot Program, an effort to provide stakeholders with more usable information on the clinical evidence supporting drug product approvals and more transparency into the FDA’s decision-making process. Soon after approval, certain information from the clinical summary report will post with the Erleada entry on Drugs@FDA and on the new pilot program landing page”.
Erleada (apalutamide) is indicated for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). Erleada was granted Priority Review.
On 22 February 2018, the European Commission (EC) published Version 2 of the expert group recommendations on Summaries of Clinical Trial Results for Laypersons. This update supersedes Version 1 dated 26 January 2017. Note that the date of entry into force is on implementation of the Clinical Trials Regulation (EU) No 536/2014. The document is available on the EudraLex – Volume 10 – Clinical Trials Guidelines web page (Chapter V – Additional Documents).
Changes in Version 2: Update to Annex 1 Section 7 regarding secondary endpoints (page 19):
Sponsors should reference the complete list of outcomes based on all endpoints available in the technical results summary for each clinical trial in the EU database including patient relevant secondary endpoints.
Source: DIA – Clinical Trial Disclosure Community