title: Randomized two-stage Phase II clinical trial designs based on Barnard's exact test.
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.
authors: Department of Environmental and Occupational Health, Epidemiology and Biostatistics Program, University of Nevada Las Vegas, Las Vegas, Nevada 89154, USA. guogen.shan@unlv.edu
authors: Guogen
authors: G
authors: Shan
authors: Changxing
authors: C
authors: Ma
authors: Alan D
authors: AD
authors: Hutson
authors: Gregory E
authors: GE
authors: Wilding
mesh_terms: D017322:Clinical Trials, Phase II as Topic / Q000379:methods* / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D003657:Decision Making; D057239:Early Termination of Clinical Trials; D023381:Endpoint Determination; D008495:Medical Oncology; D015233:Models, Statistical; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D012107:Research Design / Q000592:standards / Q000706:statistics & numerical data*; D018401:Sample Size