Monitoring of a pilot toxicity study with two adverse outcomes.
We consider monitoring a pilot toxicity study in which the adverse outcome is bivariate and the goal is to terminate the trial if evidence of excessive toxicity is encountered. We develop a Bayesian monitoring rule, based on the posterior probability that the frequency of either adverse outcome exceeds that observed under standard therapy. This rule is intuitive and ethical, and extends in a straightforward fashion from the univariate to the multivariate case. Since p-values and confidence intervals are standard methods for reporting the results of clinical trials, we also suggest how frequentist inferences may be drawn at the conclusion of a study monitored in this fashion. This work thus represents an integration of Bayesian and frequentist methodology for sequential clinical trials.
Fred Hutchinson Cancer Research Center, Seattle, WA 98104.
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Etzioni
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Pepe
D000704:Analysis of Variance; D001499:Bayes Theorem; D016026:Bone Marrow Transplantation; D002986:Clinical Trials as Topic; D006084:Graft Rejection; D006801:Humans; D015233:Models, Statistical; D015999:Multivariate Analysis; D010865:Pilot Projects; D011336:Probability; D016896:Treatment Outcome