BOIN12-PFS: A Bayesian Optimal Interval Phase I/II Design Incorporating Progression-Free Survival Endpoint.
Modern oncology drug development is increasingly focused on identifying the optimal biological dose (OBD) rather than just the maximum tolerated dose (MTD). Early-phase oncology trials have conventionally relied on short-term endpoints, such as overall response rate (ORR), to evaluate efficacy. However, there is a grow...