Title

Randomized two- stage phase II clinical trial designs based on Barnard’s exact test

Document Type

Article

Publication Date

2013

Publication Title

Journal of Biopharmaceutical Statistics

Volume

23

Issue

5

First page number:

1081

Last page number:

1090

Abstract

In areas such as oncology, two-stage designs are often preferred as compared to one-stage designs due to the ability to stop the trial early when faced with evidence of lack of sufficient efficacy and the associated sample size savings. We present exact two-stage designs based on Barnard's exact test for differences in proportions and compare the designs to those proposed by Kepner ( 2010 ) and Jung ( 2010 ). In addition, we present tables of decision rules under a variety of assumed realities for use in trial planning. The procedure is recommended for use due to the substantial sample size savings experienced.

Keywords

Barnard test; Clinical trials; Clinical trials—Methodology; Clinical trials--Statistical methods; Clinical Trials; Phase II as Topic/methods; Clinical Trials; Phase II as Topic/statistics & numerical data; Data Interpretation; Statistical; Decision making; Design—Research; Early Termination of Clinical Trials; Endpoint Determination; Medical Oncology; Minimax design; Models; Statistical; Oncology; Optimal design; Phase II design; Randomized Controlled Trials as Topic/methods; Randomized Controlled Trials as Topic/statistics & numerical data; Research Design/standards; Research Design/statistics & numerical data; Sample Size; Translating and interpreting--Data processing

Disciplines

Clinical Trials | Medicine and Health Sciences | Oncology | Statistical Methodology | Statistics and Probability | Vital and Health Statistics

Language

English

Permissions

Use Find in Your Library, contact the author, or interlibrary loan to garner a copy of the item. Publisher policy does not allow archiving the final published version. If a post-print (author's peer-reviewed manuscript) is allowed and available, or publisher policy changes, the item will be deposited.

Identifier

DOI: 10.1080/10543406.2013.813525

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