FDA Kicks Off Transparency Pilot With First Clinical Study Report Data Published
The US Food and Drug Administration (FDA) on Monday officially launched its pilot project to publicly release portions of clinical trial-related summaries from pivotal trials, with initial data coming from Janssen’s recently approved Erleada (apalutamide), which is for patients with prostate cancer that has not spread.About 1,000 pages of Janssen’s partially redacted clinical study reports for Erleada were published, including information on the trials’ protocols and statistical analysis plans. A Janssen spokesperson told Focus that the company's interest in such a transparency initiative and in furthering other research efforts coincided with its submission for Erleada. The spokesperson also said Janssen did not redact the study report or the protocol and also did not review the FDA assessment report prior to its posting.
Up to eight more recently approved new drug applications (NDAs), whose sponsors volunteer to participate, are expected to be a part of the pilot program, first announced in January.
Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, wrote in a blog post Monday that by releasing the clinical study reports, the agency hopes to enhance the accuracy of information used in scientific publications; Increase stakeholders’ understanding of the basis for FDA’s approval decisions; and inform physicians and other healthcare providers about the detailed results that regulatory decisions were based on.
The announcement and launch of the pilot project by FDA follows the European Medicines Agency’s push to release more clinical data for researchers online, though that push has also run into some legal challenges.
Clinical Data Summary Pilot Program