Randomized two-stage Phase II clinical trial designs based on

J Biopharm Stat · Jan 2013

Randomized two-stage Phase II clinical trial designs based on Barnard's exact test.

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.

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- Guogen Shan, Changxing Ma, Alan D Hutson, and Gregory E Wilding.
- Department of Environmental and Occupational Health, Epidemiology and Biostatistics Program, University of Nevada Las Vegas, Las Vegas, Nevada 89154, USA. guogen.shan@unlv.edu
- J Biopharm Stat. 2013 Jan 1;23(5):1081-90.
AbstractIn 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.

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Randomized two-stage Phase II clinical trial designs based on Barnard's exact test.

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