Efficiency of bridging between related dose finding studies
نویسندگان
چکیده
منابع مشابه
Unified approach for extrapolation and bridging of adult information in early-phase dose-finding paediatric studies.
The number of trials conducted and the number of patients per trial are typically small in paediatric clinical studies. This is due to ethical constraints and the complexity of the medical process for treating children. While incorporating prior knowledge from adults may be extremely valuable, this must be done carefully. In this paper, we propose a unified method for designing and analysing do...
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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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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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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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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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ژورنال
عنوان ژورنال: Comptes Rendus Mathematique
سال: 2013
ISSN: 1631-073X
DOI: 10.1016/j.crma.2013.01.015