Statistical Science

Continual Reassessment and Related Dose-Finding Designs

John O’Quigley and Mark Conaway

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During the last twenty years there have been considerable methodological developments in the design and analysis of Phase 1, Phase 2 and Phase 1/2 dose-finding studies. Many of these developments are related to the continual reassessment method (CRM), first introduced by O’Quigley, Pepe and Fisher (1990). CRM models have proven themselves to be of practical use and, in this discussion, we investigate the basic approach, some connections to other methods, some generalizations, as well as further applications of the model. We obtain some new results which can provide guidance in practice.

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Statist. Sci., Volume 25, Number 2 (2010), 202-216.

First available in Project Euclid: 19 November 2010

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Bayesian methods clinical trial continual reassessment method dose escalation dose-finding studies efficacy maximum likelihood maximum tolerated dose most successful dose Phase 1 trials Phase 2 trials toxicity


O’Quigley, John; Conaway, Mark. Continual Reassessment and Related Dose-Finding Designs. Statist. Sci. 25 (2010), no. 2, 202--216. doi:10.1214/10-STS332.

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