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

共 50 条

[21] Conduct of clinical trials: The pharmaceutical perspective
Porter, RJ
ARCHIVES OF NEUROLOGY, 2002, 59 (02) : 324 - 325
[22] Difficulties in the conduct of clinical trials in France
Zannad, F
Plétan, Y
THERAPIE, 2001, 56 (04): : 341 - 347
[23] Ethics in the design and conduct of clinical trials
Sugarman, J
EPIDEMIOLOGIC REVIEWS, 2002, 24 (01) : 54 - 58
[24] Improving the conduct and reporting of clinical trials
Bernhardt, H
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2000, 283 (21): : 2787 - 2787
[25] Conduct of clinical trials in developing countries
Kasper, CK
HAEMOPHILIA, 2002, 8 (03) : 166 - 169
[26] Independent design and conduct of clinical trials
Yusuf, Salim
Bosch, Jackie
CLINICAL TRIALS, 2006, 3 (06) : 503 - 507
[27] Conduct of clinical trials in developing countries
Howie, Stephen
LANCET, 2007, 370 (9587): : 562 - 562
[28] CONDUCT AND DESIGN OF CLINICAL-TRIALS
BLAKEMORE
MARKS
DERMATOLOGICA, 1976, 152 : 253 - 256
[29] THE FOCUS AND CONDUCT OF CLINICAL-TRIALS
WEST, R
BRITISH JOURNAL OF ADDICTION, 1991, 86 (05): : 663 - 666
[30] Importance of proper conduct of clinical trials
Cortegiani, Andrea
Absalom, Anthony R.
BRITISH JOURNAL OF ANAESTHESIA, 2021, 126 (02) : 354 - 356

← 1 2 3 4 5 →