Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children's Pediatric Innovation Research Forum

被引：14

作者：

Noel, Gary J. ^{[1
,2
]}

Nelson, Robert M. ^{[3
]}

Bucci-Rechtweg, Christina ^{[4
]}

Portman, Ronald ^{[4
]}

Miller, Thomas ^{[5
]}

Green, Dionna J. ^{[6
]}

Snyder, Donna ^{[6
]}

Moreno, Carmen ^{[7
]}

Hovinga, Collin ^{[1
]}

Connor, Edward ^{[1
,8
]}

机构：

[1] Inst Adv Clin Trials Children, 9211 Corp Blvd Suite 260, Rockville, MD 20850 USA

[2] Weill Cornell Med Coll, New York, NY 10021 USA

[3] Johnson & Johnson, Spring House, PA USA

[4] Novartis Pharmaceut, E Hanover, NJ USA

[5] Bayer US, Whippany, NJ USA

[6] US FDA, Silver Spring, MD USA

[7] Univ Complutense, Dept Child & Adolescent Psychiat, Hosp Gen Univ Gregorio Maranon, Sch Med,IiSGM,CIBERSAM,Inst Psychiat & Mental Hlt, Madrid, Spain

[8] George Washington Sch Med, Washington, DC USA

来源：

THERAPEUTIC INNOVATION & REGULATORY SCIENCE | 2021年 / 55卷 / 04期

关键词：

Pediatrics; Clinical trials; Adolescents; Drug development; Phase; 3; trials;

D O I：

10.1007/s43441-021-00283-y

中图分类号：

R-058 [];

学科分类号：

摘要：

Including adolescents in adult clinical trials can play an important role in making innovative new medicines available to children in a timelier fashion. Stakeholders involved in the processes leading to regulatory approval and labeling of new drugs recognize that challenges exist in involving adolescents and older children in clinical trials before the safety and efficacy of these drugs are established for adults. However, it has been possible to design and execute phase 3 trials that combine adults with adolescents which are medically and scientifically sound and ethically justified. Based on this experience and considerations of the medical and scientific, ethical, and operation-related matters, the 2019 Pediatric Innovation Research Forum advocated for the position that adolescents routinely be considered for enrollment in phase 3 clinical trials. The Forum also concluded that exclusion of adolescents in adult pivotal trials occur only when a thorough evaluation of the target disease and the potential benefit and risks of the study intervention supports a delay in their involvement until after completion of clinical trials in adults.

引用

页码：773 / 778

页数：6

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