主方案:有效临床设计策略以拓展肿瘤药物和生物制品的开发(草案)

2018-10-03 美国食品和药品监督管理局 FDA

Docket Number:

中文标题:

主方案:有效临床设计策略以拓展肿瘤药物和生物制品的开发(草案)

英文标题:

Master Protocols: Efficient Clinical Trial Design Strategies To Expedite Development of Oncology Drugs and Biologics

发布日期:

2018-10-03

简要介绍:

Docket Number:
FDA-2018-D-3292
Issued by:
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Oncology Center of Excellence

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.” This guidance provides advice to sponsors of drugs and biologics for cancer treatment regarding the design and conduct of clinical trials, other than first-in-human (FIH) trials, intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure (master protocols) in adult and pediatric cancers. In contrast to traditional trial designs, where a single drug is tested in a single disease population in one clinical trial, master protocols use a single infrastructure, trial design, and protocol to simultaneously evaluate multiple drugs and/or disease populations in multiple substudies, allowing for efficient and accelerated drug development.

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