Surrogate Endpoints in Pediatric Studies Submitted to the US FDA

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Abstract

The 21st Century Cures Act was passed in December, 2016, and included a number of provisions to facilitate drug approval. Considerable discussion was generated related to some aspects of the Act, especially to the use of surrogate endpoints (SEs) as a means to shorten the time required prior to receiving US Food and Drug Administration (FDA) approval.1 The objective of this analysis was to identify the use and outcomes of SEs and clinical endpoints in pediatric drug development trials.

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