Journal
CONTEMPORARY CLINICAL TRIALS
Volume 28, Issue 5, Pages 654-661Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2007.02.008
Keywords
clinical trials; phase 2 trials; targeted therapy; Simon Two-Stage
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The field of specialized medicine and clinical development programs for targeted cancer therapies are rapidly expanding. The proposed Phase 2 design allows for preliminary determination of efficacy that may be restricted to a particular sub-population defined by biomarker status (presence/absence). The design is an adaptation of the Simon Two-Stage Design. We provide examples where the adaptation can result in substantial savings in sample size and thus potentially lead to greater efficiency in decision making during the drug development process. (c) 2007 Elsevier Inc. All rights reserved.
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