Surrogate Endpoints in Pediatric Studies Submitted to the US FDA.

ABSTRACT: The 21^st 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.

SUBMITTER: Green DJ 

PROVIDER: S-EPMC6481930 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature