title: A design alternative for two-stage, phase II, multicenter cancer clinical trials.
abstract: Data are reviewed upon completion of patient accrual to the first stage of a two-stage phase II cancer clinical trial and prior to initiating accrual on the second stage. Often accrual must be suspended while the data from the first stage are collected and evaluated. In an effort to maintain patient accrual momentum and avoid the logistical problems of suspending and reactivating a multicenter study, an alternative approach to conducting two-stage phase II studies, which allows patient accrual to continue while the results of the first stage are reviewed, is proposed. The properties of the proposed design are examined.
authors.affiliation: Department of Community and Family Medicine and Cancer Center Biostatistics, Duke University Medical Center, Durham, North Carolina 27710, USA.
authors.forename: J E
authors.initials: JE
authors.lastname: Herndon
mesh_terms: D000465:Algorithms; D017322:Clinical Trials, Phase II as Topic / Q000379:methods*; D003625:Data Collection / Q000379:methods; D003657:Decision Making; D005069:Evaluation Studies as Topic; D006801:Humans; D015337:Multicenter Studies as Topic; D009369:Neoplasms / Q000628:therapy*; D018579:Patient Selection; D011336:Probability; D012107:Research Design; D016896:Treatment Outcome