Journal
JOURNAL OF BIOPHARMACEUTICAL STATISTICS
Volume 16, Issue 3, Pages 275-283Publisher
TAYLOR & FRANCIS INC
DOI: 10.1080/10543400600614742
Keywords
Data Monitoring Committee; dose finding; interim analysis; seamless Phase II/ III design; sample size reestimation
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A PhRMA Working Group on adaptive clinical trial designs has been formed to investigate and facilitate opportunities for wider acceptance and usage of adaptive designs and related methodologies. A White Paper summarizing the findings of the group is in preparation; this article is an Executive Summary for that full White Paper, and summarizes the findings and recommendations of the group. Logistic, operational, procedural, and statistical challenges associated with adaptive designs are addressed. Three particular areas where it is felt that adaptive designs can be utilized beneficially are discussed: dose finding, seamless Phase II/III trials designs, and sample size reestimation.
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