FDA Trials Pilot Attracts One Volunteer
The FDA’s experiment in whether it can publish the clinical trials data behind drug approvals attracted a lone volunteer and now the agency is seeking public comment on whether they should stick with the project or try something else.
In a Federal Register notice on Thursday, CDER says it wants to hear from drug companies and other interested parties on its Clinical Data Summary Report pilot project, which launched last year. The program was designed to show the work behind a drug approval, but it only attracted one volunteer — Janssen, for its prostate cancer treatment Erleada (apalutamide).
In the public notice, CDER officials say they want to hear from drug companies about their concerns, and what it would take to improve the program enough to get more volunteers.
At the same time, regulators are also taking comments on whether they should scrap the pilot and focus on a new review template for drug sponsors. Instead of having individual experts comment on a given drug application, the template — currently being implemented into drug reviews — summarizes experts’ views on a drug’s safety and efficacy.