How to Conduct Clinical Trials in Children: A Tutorial.

Creator(s)

Valentina Shakhnovich, Children's Mercy HospitalFollow
Christoph P. Hornik
Gregory L. Kearns
Jaylene Weigel, Children's Mercy HospitalFollow
Susan M. Abdel-Rahman, Children's Mercy HospitalFollow

Document Type

Article

Publication Date

5-2019

Identifier

DOI: 10.1111/cts.12615; PMCID: PMC6510379

Abstract

Despite a growing interest in, and commitment to, implementing pediatric clinical trials, approximately one in every five trials in children fails because of inappropriate study design, suboptimal experiment planning, or inadequate participant enrollment. This tutorial, presented from the perspectives of seasoned pediatric investigators, an experienced research coordinator, and an established pediatric clinical trials network, is designed to provide practical guidance for successfully implementing pediatric clinical trials at an academic center or another comparable institution.

Journal Title

Clin Transl Sci

Volume

12

Issue

3

First Page

218

Last Page

230

MeSH Keywords

Child; Clinical Trials as Topic; Drug Discovery; Ethics, Research; Humans; Infant; Infant, Newborn; Informed Consent

PubMed ID

30657253

Keywords

Child; Clinical Trials as Topic; Drug Discovery; Ethics, Research; Humans; Infant; Infant, Newborn; Informed Consent

Comments

This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

Publisher's Link: https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.12615

Recommended Citation

Shakhnovich V, Hornik CP, Kearns GL, Weigel J, Abdel-Rahman SM. How to Conduct Clinical Trials in Children: A Tutorial. Clin Transl Sci. 2019;12(3):218-230. doi:10.1111/cts.12615