title: A comparative study of matched pair designs with two binary endpoints.
abstract: We study matched pair designs with two binary endpoints under three different approaches. Power approximation and sample size calculation are derived under these situations and facilitated by R programs. An adaptive design with sample size re-estimation is also presented. Through extensive simulations, we provide general guidelines for practitioners to choose the best approach according to the ranges of the interested parameters in the sense of feasibility and robustness. Application to a cancer chemotherapy trial is illustrated.
authors: Department of Statistics and Actuarial Science, East China Normal University, Shanghai, China.
authors: Yuanyuan
authors: Y
authors: Jiang
authors: Department of Statistics and Actuarial Science, East China Normal University, Shanghai, China.
authors: Jin
authors: J
authors: Xu
mesh_terms: D056808:Biostatistics / Q000379:methods*; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D023381:Endpoint Determination / Q000706:statistics & numerical data*; D006801:Humans; D016013:Likelihood Functions; D016555:Matched-Pair Analysis; D015233:Models, Statistical; D018401:Sample Size
keywords: Binary endpoint; equivalence; matched pair design; non-inferiority