title: Two-stage sample size re-estimation based on a nuisance parameter: a review.
abstract: Sample size calculations are important and difficult in clinical trails because they depend on the nuisance parameter and treatment effect. Recently, much attention has been focused on two-stage methods whereby the first stage constitutes an internal pilot study used to estimate parameters and revise the final sample size. This paper reviews two-stage methods based on estimation of nuisance parameters in either a continuous or dichotomous outcome setting.
authors: National Heart, Lung, and Blood Institute, Bethesda, Maryland, USA. ProschaM@mail.nih.gov
authors: Michael A
authors: MA
authors: Proschan
mesh_terms: D000465:Algorithms; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003627:Data Interpretation, Statistical; D004032:Diet; D006801:Humans; D006973:Hypertension / Q000178:diet therapy; D010865:Pilot Projects; D012107:Research Design; D018401:Sample Size; D016896:Treatment Outcome