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The Milbank quarterly · Jun 2017
Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval.
- Huseyin Naci, Olivier J Wouters, Radhika Gupta, and Ioannidis John P A JPA Stanford University..
- London School of Economics and Political Science.
- Milbank Q. 2017 Jun 1; 95 (2): 261-290.
AbstractPolicy Points: Randomized trials-the gold standard of evaluating effectiveness-constitute a small minority of existing evidence on agents given accelerated approval. One-third of randomized trials are in therapeutic areas outside of FDA approval and less than half evaluate the therapeutic benefits of these agents but use them instead as common backbone treatments. Agents receiving accelerated approval are often tested concurrently in several therapeutic areas. For most agents, no substantial time lag is apparent between the average start dates of randomized trials evaluating their effectiveness and those using them as part of background therapies. There appears to be a tendency for therapeutic agents receiving accelerated approval to quickly become an integral component of standard treatment, despite potential shortcomings in their evidence base.© 2017 Milbank Memorial Fund.
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