Journal
JOURNAL OF BIOPHARMACEUTICAL STATISTICS
Volume 20, Issue 6, Pages 1115-1124Publisher
TAYLOR & FRANCIS INC
DOI: 10.1080/10543406.2010.514452
Keywords
Adaptive dose finding; Confirmatory trial; Data Monitoring Committee; Exploratory trial; Sample size reestimation
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The US Food and Drug Administration has recently released a draft guidance document on adaptive clinical trials. We comment on the document from the particular perspective of the authors as members of a PhRMA working group on this topic, which has interacted with FDA personnel on adaptive trial issue during recent years. We describe the activities and prior work of our working group, and use this as a basis to discuss the content of the guidance document as it relates to several issues of current relevance, such as data monitoring processes, adaptive dose finding, so-called seamless trial designs, and sample size reestimation.
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