title: Adaptive, group sequential and decision theoretic approaches to sample size determination.
abstract: This paper presents two adaptive methods for sample size re-estimation within a unified group sequential framework. The conceptual and practical distinction between these adaptive modifications and more traditional sample size changes due to revised estimates of nuisance parameters is highlighted. The motivation for the adaptive designs is discussed. Having established that adaptive sample size modifications can be made without inflating the type 1 error, the paper concludes with a novel decision theoretic approach for determining the magnitude of the sample size modification.
authors.affiliation: Cytel Inc., Cambridge, MA, USA. mehta@cytel.com
authors.forename: Cyrus R
authors.initials: CR
authors.lastname: Mehta
authors.forename: Nitin R
authors.initials: NR
authors.lastname: Patel
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D006801:Humans; D015233:Models, Statistical; D018401:Sample Size