How to Conduct Clinical Trials in Children: A Tutorial

被引：20

作者：

Shakhnovich, Valentina ^{[1
,2
]}

Hornik, Christoph P. ^{[3
]}

Kearns, Gregory L. ^{[4
]}

Weigel, Jaylene ^{[1
]}

Abdel-Rahman, Susan M. ^{[1
,2
]}

机构：

[1] Childrens Mercy Kansas City, Kansas City, MO 64108 USA

[2] Univ Missouri, Sch Med, Kansas City, MO 64108 USA

[3] Duke Univ, Durham, NC USA

[4] Arkansas Childrens Hosp, 800 Marshall St, Little Rock, AR 72202 USA

来源：

CTS-CLINICAL AND TRANSLATIONAL SCIENCE | 2019年 / 12卷 / 03期

关键词：

SINGLE-DOSE PHARMACOKINETICS; FAT-ABSORPTION; INFANTS; PREMATURE; TRIGLYCERIDE; DISPOSITION; PLECONARIL; EXPRESSION; ONTOGENY; DESIGN;

D O I：

10.1111/cts.12615

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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.

引用

页码：218 / 230

页数：13

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