A Call for Objective Dose Selection to Increase Success in Pediatric Clinical Trials: A Perspective From NICHD and NIMH Program Staff

Author:

Giacoia George1,Grabb Margaret C.2,Pawlyk Aaron C.1,Ren Zhaoxia1,Samedy‐Bates Lesly1,Taylor‐Zapata Perdita1

Affiliation:

1. Obstetric and Pediatric Pharmacology and Therapeutics Branch Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Bethesda Maryland USA

2. National Institute of Mental Health (NIMH) Bethesda Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference16 articles.

1. US Food and Drug Administration.FDA Public Workshop: Pediatric Dose Selection.https://www.fda.gov/drugs/news-events-human-drugs/fda-public-workshop-pediatric-dose-selection-10222020-10232020. Published 2020. Accessed March 11 2021.

2. Failed pediatric drug development trials;Momper JD;Clin Pharmacol Ther,2015

3. Toward a new era of trust and transparency in clinical trials;Hudson KL;JAMA,2016

4. National Institutes of Health Extramural Nexus.Status of Our Initiatives to Strengthen Clinical Trials.https://nexus.od.nih.gov/all/2017/01/06/status-of-our-initiatives-to-strengthen-clinical-trials/. Published 2017. Accessed March 11 2021.

5. Department of Health and Human Services.Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R01 Clinical Trial Optional).https://grants.nih.gov/grants/guide/pa-files/PAR-20-300.html. Published 2020. Accessed March 11 2021.

Cited by 1 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

1. Precision Medicine in Pediatric Cardiology;Pediatric Annals;2022-10

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