| Literature DB >> 30094815 |
Dionna J Green1, Haihao Sun2, Janelle Burnham1, Xiaomei I Liu3, John van den Anker3, Jean Temeck2, Lynne Yao3,4, Susan K McCune2, Gilbert J Burckart1.
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.Entities:
Mesh：
Substances：
Year: 2018 PMID： 30094815 PMCID： PMC6481930 DOI： 10.1002/cpt.1117
Source DB: PubMed Journal: Clin Pharmacol Ther ISSN： 0009-9236 Impact factor: 6.875