Physical Sciences and Mathematics Commons^™

Bayesian Adaptive Designs For Proof-Of-Concept Trials And Platform Trials, Yujie Zhao

Dissertations & Theses (Open Access)

With the revolutionary achievement in molecular targeted therapies and cancer immunotherapies, the traditional drug development paradigm in phase II trials becomes increasingly inefficient due to its slow progress, high cost, and high failure rate. Fitting one standard strategy to all different trials also harms its reliability in decision-making because it doesn’t fully use all available resources and information in each trial. It’s crucial to develop novel phase II trial designs to accomplish different objectives for different types of trials. This research mainly focuses on Bayesian adaptive designs for phase II trials. Three types of trials are discussed in which traditional …

Bayesian Adaptive Designs For Early Phase Clinical Trials, Chunyan Cai

Dissertations & Theses (Open Access)

My dissertation focuses mainly on Bayesian adaptive designs for phase I and phase II clinical trials. It includes three specific topics: (1) proposing a novel two-dimensional dose-finding algorithm for biological agents, (2) developing Bayesian adaptive screening designs to provide more efficient and ethical clinical trials, and (3) incorporating missing late-onset responses to make an early stopping decision.

Treating patients with novel biological agents is becoming a leading trend in oncology. Unlike cytotoxic agents, for which toxicity and efficacy monotonically increase with dose, biological agents may exhibit non-monotonic patterns in their dose-response relationships. Using a trial with two biological agents as …