title: A modification of Simon's optimal design for phase II trials when the criterion is median sample size.
abstract: We present a modification to Simon's optimal design for phase II trials in which the objective is to minimize the median sample size rather than the expected sample size when the true response rate is poor (p = p0). We argue that the modified design may be preferred in smaller institutions when the focus is on a single or small number of phase II trials rather than a large program of phase II trials.
authors.affiliation: Department of Biostatistics, Rollins School of Public Health of Emory University, Atlanta, Georgia 30322, USA.
authors.forename: J J
authors.initials: JJ
authors.lastname: Hanfelt
authors.forename: R S
authors.initials: RS
authors.lastname: Slack
authors.forename: E A
authors.initials: EA
authors.lastname: Gehan
mesh_terms: D000465:Algorithms; D017322:Clinical Trials, Phase II as Topic / Q000706:statistics & numerical data*; D015331:Cohort Studies; D003198:Computer Simulation; D004341:Drug Evaluation; D006801:Humans; D015233:Models, Statistical; D018579:Patient Selection; D011336:Probability; D012074:Remission Induction; D012107:Research Design / Q000706:statistics & numerical data*; D018401:Sample Size; D016896:Treatment Outcome