Sample size re-estimation for adaptive sequential design in clinical trials.
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.
Gao
Ping
P
Biostatistics, The Medicines Company, Parsippany, New Jersey 07054, USA. ping.gao@themedco.com
Ware
James H
JH
Mehta
Cyrus
C
D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003198:Computer Simulation; D003627:Data Interpretation, Statistical; D006801:Humans; D008390:Markov Chains; D015233:Models, Statistical; D018401:Sample Size; D013997:Time Factors; D016896:Treatment Outcome