title: Optimal designs for two-arm, phase II clinical trial design with multiple constraints.
abstract: Multi-stage Phase II trials are often employed in practice but may not be the best approach when the endpoint of interest is not obtained soon after enrollment and/or when a control arm is desired. We present a new design in which sample size determination includes a control arm and allows for the estimation of response for each treatment as well as estimation of the difference in the response rates. We evaluate this design under varying allocation schemes to treatment arms and response rates for each treatment.
authors.affiliation: Department of Biostatistics, University of Kansas Medical Center, Kansas City, Kansas 66160, USA. mmayo@kumc.edu
authors.forename: Matthew S
authors.initials: MS
authors.lastname: Mayo
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Mahnken
authors.forename: Seng-Jaw
authors.initials: SJ
authors.lastname: Soong
mesh_terms: D002985:Clinical Protocols / Q000592:standards; D017322:Clinical Trials, Phase II as Topic / Q000379:methods* / Q000592:standards* / Q000706:statistics & numerical data; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards* / Q000706:statistics & numerical data; D012107:Research Design / Q000592:standards / Q000706:statistics & numerical data