title: A model-based method for selecting an acceptable dose in phase IIa chemoprevention trials.
abstract: In a cancer chemoprevention trial, it is vitally important to use a dose that will limit intolerable side-effects. Unlike the situation with cancer drug treatment, the side-effects are relatively moderate, only rather low levels will be permitted, and the time to development of intolerability may be long and variable. These characteristics all argue in favor of a fixed-sample size, and a fixed-dose design. Here we give a very general procedure for selecting an acceptable dose for subsequent testing based on such a design. We also show how a simple program can display the characteristics of various designs graphically, permitting a common-sense selection.
authors.affiliation: Arizona Cancer Center, University of Arizona 85724, USA.
authors.forename: M
authors.initials: M
authors.lastname: Aickin
mesh_terms: D018890:Chemoprevention; D017322:Clinical Trials, Phase II as Topic / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D006801:Humans; D008962:Models, Theoretical