title: A phase II flexible screening design allowing for interim analysis and comparison with historical control.
abstract: Sargent and Goldberg [1] proposed a randomized phase II flexible screening design (SG design) which took multiple characteristics of candidate regimens into consideration in selecting a regimen for further phase III testing. In this paper, we extend the SG design by including provisions for an interim analysis and/or a comparison to a historical control. By including a comparison with a historical control, a modified SG design not only identifies a more promising treatment but also assures that the regimen has a clinically meaningful level of efficacy as compared to a historical control. By including an interim analysis, a modified SG design could reduce the number of patients exposed to inferior treatment regimens. When compared to the original SG design, the modified designs increase the sample size moderately, but expand the utility of the flexible screening design substantially.
authors.affiliation: Mayo Clinic and Mayo Foundation, Rochester, MN 55901, USA. wu.wenting@mayo.edu
authors.forename: Wenting
authors.initials: W
authors.lastname: Wu
authors.forename: Brian
authors.initials: B
authors.lastname: Bot
authors.forename: Yan
authors.initials: Y
authors.lastname: Hu
authors.forename: Susan M
authors.initials: SM
authors.lastname: Geyer
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Sargent
mesh_terms: D017322:Clinical Trials, Phase II as Topic / Q000379:methods*; D035061:Control Groups; D006801:Humans; D012107:Research Design; D013223:Statistics as Topic / Q000379:methods*
keywords: Cancer clinical trial; Flexible screening design; Historical control comparison; Interim analysis