BEACON: An Adaptive Bayesian Early-Phase Oncology Trial Design Integrating Dose Optimization and Proof-of-Concept Across Survival and Binary Endpoints.
Conventional dose selection in oncology, which focuses on the maximum tolerated dose (MTD), has certain limitations for targeted agents and immunotherapies, where the efficacy-toxicity relationship may not be monotonic. Regulatory initiatives such as FDA's Project Optimus highlight the need for improved dose optimizati...