Estimating the probability of toxicity at the target dose following an up-and-down design

Stat Med. 2003 Feb 28;22(4):535-43. doi: 10.1002/sim.1351.

Abstract

One of the most important aspects of a phase I trial or other acute toxicity study is estimating accurately the probability of toxicity that is associated with the recommended dose. We use the biased coin up-and-down design to allocate and isotonic regression to estimate toxicity probabilities and determine the recommended dose. We then derive, using bootstrap methods, an estimate of the probability of toxicity at the recommended dose. Small sample properties of this estimator are also evaluated. Published in 2003 by John Wiley & Sons, Ltd.

Publication types

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

MeSH terms

  • Bias
  • Clinical Trials, Phase I as Topic / statistics & numerical data*
  • Dose-Response Relationship, Drug
  • Drug-Related Side Effects and Adverse Reactions*
  • Humans
  • Probability*
  • Regression Analysis
  • Research Design / statistics & numerical data*
  • United States