An FDA pilot program that offers real-time review of oncology trial data is a positive move toward speeding drug development, sponsor participants say.
“We think what the agency is doing is a net positive for patients and industry,” says Michael Meo, director of global media relations for Novartis Oncology Communications & Advocacy. Novartis was the first participant to win approval for its drug, Kisqali, under the accelerated program.
Despite EU requirements for clinical trials to report results to the EU Clinical Trials Register within a year of a trial’s completion, sponsors have only reported about half of them so far. Read More
In a widely expected move, HHS issued a final rule to once again delay implementation of the revised Common Rule on the protection of human subjects in clinical trials until Jan. 21, 2019, and to permit an exception from the existing federal policy for three burden-reducing provisions during the delay period. Read More
The FDA finalized guidance on its special protocol assessment (SPA) program that offers sponsors an advanced declaration from the agency that their trial designs, clinical endpoints and statistical analyses are acceptable. Read More
The process of selecting clinical trial sites and launching studies, beginning with site identification and ending with study start-up completion, takes an average of 31.4 weeks for Phase II and III studies — a full month longer than the average seen 10 years ago, according to a survey conducted by the Tufts Center for the Study of Drug Development. Read More
