Surrogate Endpoints in Pediatric Studies Submitted to the US FDA. Issue 3 (9th August 2018)

• Record Type: Journal Article
• Authors: Green, Dionna J.; Sun, Haihao; Burnham, Janelle; Liu, Xiaomei I.; van den Anker, John; Temeck, Jean; Yao, Lynne; McCune, Susan K.; Burckart, Gilbert J.
• Is Part Of: Clinical pharmacology & therapeutics. Volume 105:Issue 3(2019)
• Page Start: 555
• Page End: 557
• Publication Date: 2018-08-09
• Subjects: Pharmacology -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1002/cpt.1117
• Languages: English
• ISSNs: 0009-9236

Abstract

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.