Surrogate Endpoints in Pediatric Studies Submitted to the US FDA.
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ABSTRACT:
SUBMITTER: Green DJ
PROVIDER: S-EPMC6481930 | biostudies-literature | 2019 Mar
REPOSITORIES: biostudies-literature
Publications
Surrogate Endpoints in Pediatric Studies Submitted to the US FDA.
Green Dionna J DJ Sun Haihao H Burnham Janelle J Liu Xiaomei I XI van den Anker John J Temeck Jean J Yao Lynne L McCune Susan K SK Burckart Gilbert J GJ
Clinical pharmacology and therapeutics 20180809 3
The 21<sup>st</sup> 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.<sup>1</sup> The objective of this analysis was to identify the use and outcomes of SEs and clinical endpoints in pediatric drug develop ...[more]
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