title: Estimating the probability of toxicity at the target dose following an up-and-down design.
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.
authors.affiliation: Office of Biostatistics Research, National Heart, Lung, and Blood Institute/NIH, 6701 Rockledge Drive, Room 8220, Bethesda, MD 20892, U.S.A. StylianM@nih.gov
authors.forename: Mario
authors.initials: M
authors.lastname: Stylianou
authors.forename: Michael
authors.initials: M
authors.lastname: Proschan
authors.forename: Nancy
authors.initials: N
authors.lastname: Flournoy
mesh_terms: D015982:Bias; D017321:Clinical Trials, Phase I as Topic / Q000706:statistics & numerical data*; D004305:Dose-Response Relationship, Drug; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D011336:Probability; D012044:Regression Analysis; D012107:Research Design / Q000706:statistics & numerical data*; D014481:United States