Escalation, group and A + B designs for dose-finding trials

Stat Med. 2006 Nov 15;25(21):3668-78. doi: 10.1002/sim.2470.

Abstract

In this paper, rules are given on how to construct escalation, A + B, and group designs for dose-finding trials. Operational characteristics of these designs are discussed and compared via simulations. Dose-finding designs for trials with ordinal toxicity outcome are considered.

MeSH terms

  • Clinical Trials, Phase I as Topic
  • Drug-Related Side Effects and Adverse Reactions*
  • Humans
  • Models, Statistical*
  • Pharmaceutical Preparations / administration & dosage*

Substances

  • Pharmaceutical Preparations