Journal
JOURNAL OF BIOPHARMACEUTICAL STATISTICS
Volume 21, Issue 5, Pages 871-887Publisher
TAYLOR & FRANCIS INC
DOI: 10.1080/10543406.2011.589638
Keywords
Adaptive designs; Bayesian hierarchical models; Implants; Noninferiority; Software
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Bayesian statistical methodology has been used for more than 10 years in medical device premarket submissions to the U.S. Food and Drug Administration (FDA). A complete list of the publicly available information associated with these FDA applications is presented. In addition to the increasing number of Bayesian methodological papers in the statistical journals, a number of successful Bayesian clinical trials in the biomedical journals have been recently reported. Some challenges that require more methodological development are discussed. The promise of using Bayesian methods for incorporation of prior information as well as for conducting adaptive trials is great.
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