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Statistica Sinica 17(2007), 531-547





BAYESIAN DOSE FINDING IN PHASE I CLINICAL TRIALS

BASED ON A NEW STATISTICAL FRAMEWORK


Y. Ji, Y. Li and G. Yin


The University of Texas M. D. Anderson Cancer Center


Abstract: Phase I clinical trials aim to find the maximum tolerated dose of an experimental drug. We consider dose escalation, de-escalation, or staying at the current dose as three different stochastic moves over the lattice of a sequence of prespecified dose levels. Each move is chosen by minimizing an expected penalty that determines the dose level for treating the next cohort of patients. We develop a stopping rule under which the termination of the trial ensures that the posterior probability that the current dose is the maximum tolerated dose is larger than a prespecified value. Under a new class of priors, posterior estimates for the dose toxicity probabilities are obtained using the Markov chain Monte Carlo method. We demonstrate the new designs using a real phase I clinical trial.



Key words and phrases: Markov chain Monte Carlo, penalty, stopping rule, stochastic moves, toxicity.

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