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

Implicit in the drug-approval process is a host of decisions—target patient population, control group, primary endpoint, sample size, follow-up period, etc.—all of which determine the trade-off between Type I and Type II error. We explore the application of Bayesian decision analysis (BDA) to minimi...

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Bibliographic Details
Main Authors:	Isakov, L. (Author), Lo, A.W (Author), Montazerhodjat, V. (Author)
Format:	Article
Language:	English
Published:	Elsevier Ltd 2019
Subjects:	Adaptive design Adaptive designs Bayesian decision analysis Clinical trial design Clinical trial designs Cost benefit analysis Decision making Diseases Drug-approval process Economic and social effects FDA Pancreatic cancers Patient population Randomized clinical trials Type I and type II errors
Online Access:	View Fulltext in Publisher

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View Fulltext in Publisher

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

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