title: Sample size re-estimation for adaptive sequential design in clinical trials.
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.
authors.affiliation: Biostatistics, The Medicines Company, Parsippany, New Jersey 07054, USA. ping.gao@themedco.com
authors.forename: Ping
authors.initials: P
authors.lastname: Gao
authors.forename: James H
authors.initials: JH
authors.lastname: Ware
authors.forename: Cyrus
authors.initials: C
authors.lastname: Mehta
mesh_terms: 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