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Sample Size Re-Estimation for Adaptive Sequential Design in Clinical Trials

2008; Taylor & Francis; Volume: 18; Issue: 6 Linguagem: Inglês

10.1080/10543400802369053

1520-5711

Ping Gao, James H. Ware, Cyrus R. Mehta,

Health Systems, Economic Evaluations, Quality of Life

Abstract There is considerable interest in methods that use accumulated data to modify trial sample size. However, sample size re-estimation in group sequential designs has been controversial. We describe a method for sample size re-estimation at the penultimate stage of a group sequential design that achieves specified power against an alternative hypothesis corresponding to the current point estimate of the treatment effect. Key Words: Adaptive designBrownian motionConditional powerMarkov processSample size re-estimationSequential designTransition function ACKNOWLEDGMENT The authors had helpful discussions with Tommy Fu. Notes Spending rule = O′Brien–Fleming, P 1 = 0.1, P 2 = 0.065, N 1 = N 2 = 1044, Power = 80%, Total α = 0.025 one-sided. ACR=Adjusting the Final Critical Region method; CHW=Cui, Hung, and Wang method; MS = Müller and Schäfer method.