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A design for phase I trials in completely or partially ordered groups
Author(s) -
Conaway Mark R.
Publication year - 2017
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.7295
Subject(s) - maximum tolerated dose , toxicity , parametric statistics , mathematics , phase (matter) , statistics , computer science , algorithm , medicine , chemistry , organic chemistry
We propose a design for dose finding for cytotoxic agents in completely or partially ordered groups of patients. By completely ordered groups, we mean that prior to the study, there is clinical information that would indicate that for a given dose, the groups can be ordered with respect to the probability of toxicity at that dose. With partially ordered groups, at a given dose, only some of the groups can be ordered with respect to the probability of toxicity at that dose. The method we propose includes elements of the parametric model used in the continual reassessment method combined with the Hwang‐Peddada order‐restricted estimation procedure. We evaluate the operating characteristics of these designs in a family of dose–toxicity curves representing complete and partial orders. Copyright © 2017 John Wiley & Sons, Ltd.