FDA成人肿瘤临床试验纳入青少年患者的共识

中文标题：

FDA成人肿瘤临床试验纳入青少年患者的共识

英文标题：

Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials

发布机构：

美国食品和药品监督管理局

发布日期：

2019-09-02

简要介绍：

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.” The purpose of this guidance is to provide the pharmaceutical industry, clinical investigators, and institutional review boards with information to facilitate the inclusion of adolescent patients (for purposes of this guidance, defined as ages 12 to 17) in relevant adult oncology clinical trials. The guidance focuses on appropriate patient selection criteria for the inclusion of adolescent patients in adult oncology clinical trials at various stages of drug development, considerations for dosing and pharmacokinetic evaluations, safety monitoring, and ethical considerations.

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