STAT+: Many trials to confirm benefits of drugs granted accelerated approvals are running late
Amid heightened debate over a regulatory program for speeding the approval of some medicines, a new government analysis finds extensive delays in the clinical trials that drug makers are required to conduct after approvals.
At issue is accelerated approval, which the U.S. Food and Drug Administration established in 1982 in an effort to get medicines for hard-to-treat diseases to patients sooner than they might under the usual pathways to the marketplace. As a condition of approval, a pharmaceutical company must confirm the effectiveness of its medicine through one or more clinical trials by a certain date.
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