title: Curtailed two-stage matched pairs design in double-arm Phase II clinical trials.
abstract: This article proposes a curtailed two-stage matched pairs design to shorten the drug development process in Phase II clinical trials for which there are two arms, a treatment arm and a control arm, and the primary goal being to test whether the treatment is significantly better than the control. The design presented in this article uses the inverse trinomial distribution to determine appropriate cutoff points for the termination or continuation of the trial at each stage and is best suited for trials in which there is a low success rate and the available sample size is limited, such as is the case for trials involving rare forms of cancer or other uncommon diseases.
authors.affiliation: a Department of Mathematics , SUNY Cortland , Cortland , New York , USA.
authors.forename: Christa
authors.initials: C
authors.lastname: Carsten
authors.affiliation: b Department of Mathematics , Syracuse University , Syracuse , New York , USA.
authors.forename: Pinyuen
authors.initials: P
authors.lastname: Chen
mesh_terms: D017322:Clinical Trials, Phase II as Topic; D003627:Data Interpretation, Statistical; D006801:Humans; D009369:Neoplasms; D012107:Research Design; D018401:Sample Size
keywords: Curtailed two-stage design; Phase II clinical trial; double-arm; expected sample size; matched pairs