Is the FDA too conservative or too aggressive?: a Bayesian decision analysis of clinical trial design

DOI10.1016/J.JECONOM.2018.12.009MaRDI QIDQ2000854zbMATH OpenOpenAlexFDO

Authors Leah Isakov, Andrew W. Lo, Vahid Montazerhodjat

Publication date 1 July 2019

Published in Journal of Econometrics (Search for Journal in Brave)

Full work available at URL https://doi.org/10.1016/j.jeconom.2018.12.009

zbMATH Keywords

clinical trial designadaptive designFDABayesian decision analysisdrug-approval process

Mathematics Subject Classification ID

Applications of statistics to biology and medical sciences; meta analysis (62P10) Bayesian problems; characterization of Bayes procedures (62C10)

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Cites work

• scientific article; zbMATH DE number 4078557 (Why is no real title available?)
• scientific article; zbMATH DE number 3357742 (Why is no real title available?)
• Bayesian Approaches to Randomized Trials
• Bayesian statistics and the efficiency and ethics of clinical trials
• Choosing sample size for a clinical trial using decision analysis
• Clinical Trials
• Interim Analysis in Clinical Trials: The Role of the Likelihood Principle

Cited in

(3)

• Bayesian meta-experimental design: evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes
• Randomized phase III oncology trials: a survey and empirical Bayes inference
• Annals issue in honor of Jerry A. Hausman. Editors' introduction

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