期刊
JACC-BASIC TO TRANSLATIONAL SCIENCE
卷 4, 期 3, 页码 428-437出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacbts.2019.02.005
关键词
adaptive design; biomarker studies; false discovery rate; multiplicity problem; phase II clinical trials
Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: >30% of drugs entering phase II studies fail to progress, and >58% of drugs go on to fail in phase III. Adaptive clinical trial design has been proposed as a way to reduce the costs of phase II testing by providing earlier determination of futility and prediction of phase III success, reducing overall phase II and III trial sizes, and shortening overall drug development time. This review examines issues in phase II testing and adaptive trial design. (C) 2019 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据