Bayesian methods for phase I clinical trials

Phase I clinical trials are conducted to determine the dose-response curve of a new drug with respect to toxic side effects and, in particular, to estimate the maximum tolerated dose (MTD). In this paper we take a Bayesian approach to the problem of making inferences about the MTD. Working with broa...

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Bibliographic Details
Published inStatistics in medicine Vol. 11; no. 10; p. 1377
Main Authors Gatsonis, C, Greenhouse, J B
Format Journal Article
LanguageEnglish
Published England 1992
Subjects
Algorithms
Animals
Bayes Theorem
Clinical Trials as Topic
Dose-Response Relationship, Drug
Drug Evaluation
Drug-Related Side Effects and Adverse Reactions
Ethics, Medical
Humans
Interferon-gamma - therapeutic use
Likelihood Functions
Mice
Models, Statistical
Neoplasms - drug therapy
Risk
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Summary:Phase I clinical trials are conducted to determine the dose-response curve of a new drug with respect to toxic side effects and, in particular, to estimate the maximum tolerated dose (MTD). In this paper we take a Bayesian approach to the problem of making inferences about the MTD. Working with broad classes of priors, we obtain the posterior distribution of the MTD and study its properties. We also address the question of providing updated assessments of the risk of toxicity for new patients entering the study at a specific dose level. These assessments would be useful in deciding issues of study management and ethics. Our analysis pays particular attention to the sensitivity of the inferences and risk assessments to the choice of prior and the choice of model for the dose-response relationship.
ISSN:0277-6715
1097-0258
DOI:10.1002/sim.4780111011