Journal
NATURE REVIEWS CLINICAL ONCOLOGY
Volume 15, Issue 10, Pages 596-597Publisher
NATURE PUBLISHING GROUP
DOI: 10.1038/s41571-018-0066-3
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Funding
- Laura and John Arnold Foundation
- Engelberg Foundation
- Harvard Program in Therapeutic Science
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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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