Continual reassessment and related designs in dose-finding studies
نویسندگان
چکیده
منابع مشابه
Continual Reassessment and Related Dose-Finding Designs.
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 inves...
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The continual reassessment method (CRM) is a commonly used dose-finding design for phase I clinical trials. Practical applications of this method have been restricted by two limitations: (1) the requirement that the toxicity outcome needs to be observed shortly after the initiation of the treatment; and (2) the potential sensitivity to the prespecified toxicity probability at each dose. To over...
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In the dose–finding setting, we discuss and compare adaptive designs, including those which allocate each new patient (or a cohort of patients) to the dose currently viewed as the best one, for example, the seemingly most efficacious. We call this type of allocation “best intention” designs and found that, similar to other areas of life, the best intention may pave the road to rather disastrous...
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A major practical impediment when implementing adaptive dose-finding designs is that the toxicity outcome used by the decision rules may not be observed shortly after the initiation of the treatment. To address this issue, we propose the data augmentation continual re-assessment method (DA-CRM) for dose finding. By naturally treating the unobserved toxicities as missing data, we show that such ...
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Identifying the “right” dose is one of the most critical and difficult steps in the clinical development process of any medicinal drug. Its importance cannot be understated: selecting too high a dose can result in unacceptable toxicity and associated safety problems, while choosing too low a dose leads to smaller chances of showing sufficient efficacy in confirmatory trials, thus reducing the c...
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ژورنال
عنوان ژورنال: Statistics in Medicine
سال: 2011
ISSN: 0277-6715
DOI: 10.1002/sim.4215