Title | Bayesian design of noninferiority trials for medical devices using historical data. |
Publication Type | Journal Article |
Year of Publication | 2011 |
Authors | Chen, Ming-Hui, Joseph G. Ibrahim, Peter Lam, Alan Yu, and Yuanye Zhang |
Journal | Biometrics |
Volume | 67 |
Issue | 3 |
Pagination | 1163-70 |
Date Published | 2011 Sep |
ISSN | 1541-0420 |
Keywords | Bayes Theorem, Biometry, Clinical Trials as Topic, Computer Simulation, Data Interpretation, Statistical, Equipment and Supplies, Humans, Models, Statistical, Research Design, Sample Size |
Abstract | We develop a new Bayesian approach of sample size determination (SSD) for the design of noninferiority clinical trials. We extend the fitting and sampling priors of Wang and Gelfand (2002, Statistical Science 17, 193-208) to Bayesian SSD with a focus on controlling the type I error and power. Historical data are incorporated via a hierarchical modeling approach as well as the power prior approach of Ibrahim and Chen (2000, Statistical Science 15, 46-60). Various properties of the proposed Bayesian SSD methodology are examined and a simulation-based computational algorithm is developed. The proposed methodology is applied to the design of a noninferiority medical device clinical trial with historical data from previous trials. |
DOI | 10.1111/j.1541-0420.2011.01561.x |
Alternate Journal | Biometrics |
Original Publication | Bayesian design of noninferiority trials for medical devices using historical data. |
PubMed ID | 21361889 |
PubMed Central ID | PMC3136555 |
Grant List | P30 ES010126 / ES / NIEHS NIH HHS / United States R01 GM070335-12 / GM / NIGMS NIH HHS / United States CA 74015 / CA / NCI NIH HHS / United States R01 GM070335 / GM / NIGMS NIH HHS / United States GM 70335 / GM / NIGMS NIH HHS / United States R01 CA074015-12 / CA / NCI NIH HHS / United States P01 CA142538 / CA / NCI NIH HHS / United States R01 CA074015 / CA / NCI NIH HHS / United States |
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