Journal
JACC-BASIC TO TRANSLATIONAL SCIENCE
Volume 4, Issue 3, Pages 428-437Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacbts.2019.02.005
Keywords
adaptive design; biomarker studies; false discovery rate; multiplicity problem; phase II clinical trials
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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.
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