Surrogate Endpoints in Pediatric Studies Submitted to the US FDA

The 21 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 receiv...

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Bibliographic Details
Published inClinical pharmacology and therapeutics Vol. 105; no. 3; p. 555
Main 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
Format Journal Article
LanguageEnglish
Published United States 01.03.2019
Subjects
Biomarkers
Child
Clinical Trials as Topic - methods
Clinical Trials as Topic - standards
Drug Approval - methods
Humans
United States
United States Food and Drug Administration - standards
United States
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Summary:The 21 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. The objective of this analysis was to identify the use and outcomes of SEs and clinical endpoints in pediatric drug development trials.
ISSN:1532-6535
DOI:10.1002/cpt.1117