Accelerated approval enables investigational drugs to reach the US market on the basis of their demonstrated effects in unvalidated surrogate measures, only reasonably likely to predict clinical response. To fulfil the social compromise, regulators should ensure that confirmatory trials testing clinically meaningful end points are already underway at the time of approval.
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The work of A.S.K. and B.G. on this project was funded by the Laura and John Arnold Foundation. A.S.K. receives grant support from the Engelberg Foundation and the Harvard Program in Therapeutic Science. These funders had no role in any aspect related to the publication of this manuscript.
A.S.K. has received unrelated research funding from the FDA Division of Health Communication and Office of Generic Drugs (2013–2016). B.G. declares no competing interests.
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Gyawali, B., Kesselheim, A.S. Reinforcing the social compromise of accelerated approval. Nat Rev Clin Oncol 15, 596–597 (2018). https://doi.org/10.1038/s41571-018-0066-3
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