Abstract

Clinical drug trials are costly and time-consuming. Bayesian methods alleviate the inefficiencies in the testing process while providing user-friendly probabilistic inference and predictions from the sampled posterior distributions, saving resources, time, and money. We propose a dynamic linear model to estimate the mean response at each dose level, borrowing strength across dose levels. Our model permits nonmonotonicity of the dose-response relationship, facilitating precise modeling of a wider array of dose-response relationships (including the possibility of toxicity). In addition, we incorporate an adaptive approach to the design of the clinical trial, which allows for interim decisions and assignment to doses based on dose-response uncertainty and dose efficacy. The interim decisions we consider are stopping early for success and stopping early for futility, allowing for patient and time savings in the drug development process. These methods complement current clinical trial design research.

Degree

College and Department

Physical and Mathematical Sciences; Statistics

Rights

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