Bayesian Approach to Noninferiority Trials for Proportions
Author:
Affiliation:
1. a Office of Biostatistics, Food and Drug Administration , Silver Spring, Maryland, USA
2. b Department of Statistics , University of Connecticut , Storrs, Connecticut, USA
Publisher
Informa UK Limited
Subject
Pharmacology (medical),Pharmacology,Statistics and Probability
Link
https://www.tandfonline.com/doi/pdf/10.1080/10543406.2011.589646
Reference15 articles.
1. CDER/FDA Guidance for Industry . ( 2010 ). Noninferiority clinical trials. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM202140.pdf
2. CDRH/FDA Guidance for Industry and FDA Staff . ( 2010 ). Guidance for the use of Bayesian statistics in medical device clinical trials. Available at http://www.fda.gov/MedicalDevises/DeviceRegulationandGuidance/GuidanceDocuments/ucm071072.htm (last accessed July 2011)
3. Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics
4. Statistical Methods for Comparison to Placebo in Active-Control Trials
5. Hobbs , B. P. Carlin , B. P. Mandrekar , S. Sargent , D. J. ( 2011 ). Hierarchical commensurate and power prior models for adaptive incorporation of historical information in clinical trials. Biometrics, in press .
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