A model-based method for selecting an acceptable dose in phase IIa chemoprevention trials

In Vivo. May-Jun 1997;11(3):275-9.

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.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Chemoprevention*
  • Clinical Trials, Phase II as Topic / methods*
  • Dose-Response Relationship, Drug
  • Humans
  • Models, Theoretical*