Bayesian approaches in medical device clinical trials: A discussion with examples in the regulatory setting

Journal of Biopharmaceutical Statistics

Volumn 21, Issue 5, 2011, Pages 938-953

  Bonangelino, Pablo ^a   Irony, Telba ^a   Liang, Shengde ^a   Li, Xuefeng ^a   Mukhi, Vandana ^a   Ruan, Shiling ^a   Xu, Yunling ^a   Yang, Xiting ^a   Wang, Chenguang ^a  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

Bayesian adaptive designs; Bayesian hierarchical models; Clinical significance; Multiregional clinical trial; Prior distribution; Regulatory agency; Subgroup analysis

Indexed keywords

ARTICLE; BAYESIAN LEARNING; CLINICAL TRIAL (TOPIC); DEVICE; FOOD AND DRUG ADMINISTRATION; PRIORITY JOURNAL; SAFETY; STATISTICAL MODEL;

ANGIOPLASTY; BAYES THEOREM; CLINICAL TRIALS AS TOPIC; DEVICE APPROVAL; EQUIPMENT AND SUPPLIES; EQUIPMENT SAFETY; GOVERNMENT REGULATION; HUMANS; MODELS, STATISTICAL; MULTICENTER STUDIES AS TOPIC; MYOCARDIAL INFARCTION; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; STENTS; TREATMENT OUTCOME; UNITED STATES;

EID: 80051722764     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543406.2011.589650     Document Type: Article

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