Bayesian models and decision algorithms for complex early phase clinical trials
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Abstract: An early phase clinical trial is the first step in evaluating the effects in humans of a potential new anti-disease agent or combination of agents. Usually called "phase I" or "phase I/II" trials, these experiments typically have the nominal scientific goal of determining an acceptable dose, most often based on adverse event probabilities. This arose from a tradition of phase I trials to evaluate cytotoxic agents for treating cancer, although some methods may be applied in other medical settings, such as treatment of stroke or immunological diseases. Most modern statistical designs for early phase trials include model-based, outcome-adaptive decision rules that choose doses for successive patient cohorts based on data from previous patients in the trial. Such designs have seen limited use in clinical practice, however, due to their complexity, the requirement of intensive, computer-based data monitoring, and the medical community's resistance to change. Still, many actual applications of model-based outcome-adaptive designs have been remarkably successful in terms of both patient benefit and scientific outcome. In this paper I will review several Bayesian early phase trial designs that were tailored to accommodate specific complexities of the treatment regime and patient outcomes in particular clinical settings.
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Cites work
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Cited in
(12)- scientific article; zbMATH DE number 7513920 (Why is no real title available?)
- Bayesian design of biosimilars clinical programs involving multiple therapeutic indications
- Bayesian uncertainty directed trial designs
- DICE: A Bayesian model for early dose finding in phase I trials with multiple treatment courses
- Bayesian Model Averaging Continual Reassessment Method in Phase I Clinical Trials
- A Bayesian decision‐theoretic approach to incorporate preclinical information into phase I oncology trials
- Adaptive clinical trial designs for phase I cancer studies
- Using joint utilities of the times to response and toxicity to adaptively optimize schedule-dose regimes
- Stochastic approximation and modern model-based designs for dose-finding clinical trials
- Bayesian decision procedures based on logistic regression models for dose-finding studies
- A Bayesian stochastic approximation method
- A multistate model for early decision-making in oncology
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