Adaptive designs for dose-finding based on efficacy–toxicity response

We propose a new adaptive procedure for dose-finding in clinical trials when both efficacy and toxicity responses are available. We model the distribution of this bivariate binary endpoint using either Gumbel bivariate logistic regression or Cox bivariate binary model. In both cases, the analytic fo...

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Bibliographic Details
Published in:Journal of statistical planning and inference 2006-06, Vol.136 (6), p.1800-1823
Main Authors: Dragalin, Vladimir, Fedorov, Valerii
Format: Article
Language:English
Subjects:
Adaptive design
Applications
Combinatorics
Combinatorics. Ordered structures
Cox bivariate binary model
Designs and configurations
Dose-finding
Exact sciences and technology
Experimental design
General topics
Gumbel logistic regression model
Information matrix
Mathematics
Medical sciences
Optimal experimental design
Optimal safe dose
Phase I/II clinical trials
Probability and statistics
Sciences and techniques of general use
Statistics
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Summary:We propose a new adaptive procedure for dose-finding in clinical trials when both efficacy and toxicity responses are available. We model the distribution of this bivariate binary endpoint using either Gumbel bivariate logistic regression or Cox bivariate binary model. In both cases, the analytic formulae for the Fisher information matrix are obtained, that form the basis for derivation of the locally optimal and adaptive designs.
ISSN:0378-3758
1873-1171
DOI:10.1016/j.jspi.2005.08.005