Abstract
This cross-sectional study compares the duration of postapproval trials with that of the pivotal trials used as the basis for the US Food and Drug Administration’s (FDA’s) approval for all indications receiving accelerated approval from 2009-2018.
Highlights
Under the US Food and Drug Administration’s (FDA’s) accelerated approval program, therapeutic agents that address serious or life-threatening disease can receive conditional approval on the basis of trials that use surrogate markers that are reasonably likely to predict clinical benefit.[1]
For indications with more than 1 pivotal study and/or postapproval trial, we calculated the median of the trial durations
We calculated the difference between the durations of the postapproval and pivotal trials
Summary
Under the US Food and Drug Administration’s (FDA’s) accelerated approval program, therapeutic agents that address serious or life-threatening disease can receive conditional approval on the basis of trials that use surrogate markers that are reasonably likely to predict clinical benefit.[1]. Drug sponsors are required to conduct postapproval trials to confirm clinical benefit, the amount of time sponsors are granted by the FDA to complete these studies has come under increased scrutiny after the recent accelerated approval of aducanumab for Alzheimer disease,[2] which included a 9-year deadline for the completion of the confirmatory trial. Better understanding whether postapproval trial durations, which are generally expected to measure clinical outcomes and be longer than pivotal trials focused on surrogate markers, justify the study timelines set by the FDA is critical because these drugs can remain on the market for an extended period without confirmatory evidence. We compared the duration of postapproval trials with that of the pivotal trials used as the basis for the FDA’s approval, as well as FDA-established postapproval trial results reporting deadlines, for all indications receiving accelerated approval from January 1, 2009, through December 31, 2018.
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