Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration.

Abstract

Clinical trial enrichment involves prospectively incorporating trial design elements that increase the probability of detecting a treatment effect. The use of enrichment strategies in pediatric drug development has not been systematically assessed. We analyzed the use of enrichment strategies in pediatric trials submitted to the US Food and Drug… (More)
DOI: 10.1002/cpt.971

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@article{Green2017EnrichmentSI, title={Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration.}, author={Dionna J Green and Xiaomei Liu and Tianyi Hua and Janelle M Burnham and Robert N. Schuck and Michael A Pacanowski and Lynne P. Yao and Susan K. McCune and Gilbert J. Burckart and Issam Zineh}, journal={Clinical pharmacology and therapeutics}, year={2017} }