Abstract
SUMMARY. Ethical constraints and small sample size requirements are the main challenges in designing phase I clinical trials in oncology. Without using randomization, a sound design must be able to locate the maximum tolerated dose by searching the one-dimensional domain of dose levels with relatively little information. After examining the available methodologies in the literature, we propose a new dose-assignment rule and Bayesian design that differ from previous methods in several aspects. The proposed design does not require a dose-toxicity curve and bases dose-assignment decisions only on the toxicity estimates of the current dose at which patients are treated. We propose a new parametrization for the toxicity probabilities, which facilitates prior construction. We establish the asymptotic properties of the proposed design and examine its finite sample properties through extensive simulations.
Disciplines
Clinical Trials
Suggested Citation
Ji, Yuan; Li, Yisheng; and Bekele, Benjamin, "A New Dose-Assignment Rule and Bayesian Design in Phase I Oncology Trials" (October 2005). UT MD Anderson Cancer Center Department of Biostatistics Working Paper Series. Working Paper 10.
http://biostats.bepress.com/mdandersonbiostat/paper10