报告时间:12月23日9:30
报告地点:统计楼105
报告主题:BOIN: a new Bayesian paradigm for phase I clinical trials
报告人:Ying Yuan教授 美国德州大学MDAnderson癌症中心
摘要:
Despite more than two decades of publications that offer more innovative model-based designs, the classical 3+3 design remains the most dominant phase I trial design in practice. In this talk, I introduce a new trial design paradigm, the Bayesian optimal interval (BOIN) design. The BOIN design is easy to implement in a way similar to the 3+3 design, but is more flexible for choosing the target toxicity rate and cohort size and yields a substantially better performance that is comparable to that of more complex model-based designs. The BOIN design contains the 3+3 design and the accelerated titration design as special cases, thus linking it to established phase I approaches. A numerical study shows that the BOIN design generally outperforms the 3+3 design and the modified toxicity probability interval (mTPI) design. The BOIN design is more likely than the 3+3 design to correctly select the maximum tolerated dose (MTD) and allocate more patients to the MTD. Compared to the mTPI design, the BOIN design has a substantially lower risk of overdosing patients and often a higher probability of correctly selecting the MTD. User-friendly software is freely available to facilitate the application of the BOIN design. I will also discuss how to use the BOIN design for drug combination trials.