Oncology Drug Development – FDA Suggests New Trial Designs for Accelerated Approvals

02 Oct Oncology Drug Development – FDA Suggests New Trial Designs for Accelerated Approvals

The FDA officials urge sponsors to initiate a single randomized trial prior to receiving accelerated approval or conduct a single-group accelerated-approval study in patients without other available therapy, concurrently with a randomized trial with the potential to demonstrate clinical benefit in patients who have received fewer treatments.
(Ref: Fashoyin-Aje LA et al, N Engl J Med. Sep 21,2022)

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