Inclusion of Adolescents With Adults in Phase 3 Clinical Trials: Overview of the Current State and a Call for Action
Inclusion of Adolescents With Adults in Phase 3 Clinical Trials: Overview of the Current State and a Call for Action
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DOI：
10.1002/jcph.1591
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发表时间：
2020-03-02
影响因子：
2.9
通讯作者：
Hassan, Hazem E.
中科院分区：
文献类型：
--
作者：
Mohamed, Mohamed-Eslam F.;Rakhmanina, Natella;Hassan, Hazem E.
本文考虑在3期临床试验中纳入青少年和成人。所涉及的主题包括目前将青少年患者纳入儿科试验的方法，由此导致的青少年获得有效治疗的延迟，以及缺乏重要的生理基础来表明青少年和成人之间不同的疗效或安全性。
The article considers the inclusion of adolescents with adults in phase 3 clinical trials. Topics covered include the current approach of including adolescent patients within the pediatric trials, the resulting delay in the access of adolescents to efficacious treatments, and the lack of significant physiological basis to suggest different efficacy or safety profiles between adolescents and adults.