Chapter 3 Phase I/II designs

TEPI-2 & UBI

link

(Li et al. 2020)

References

Li, Pin, Rachael Liu, Jianchang Lin, and Yuan Ji. 2020. “TEPI-2 and UBI: Designs for Optimal Immuno-Oncology and Cell Therapy Dose Finding with Toxicity and Efficacy.” Journal of Biopharmaceutical Statistics 30 (6): 979–92.
Lin, Ruitao, and Guosheng Yin. 2017. “STEIN: A Simple Toxicity and Efficacy Interval Design for Seamless Phase i/II Clinical Trials.” Statistics in Medicine 36 (26): 4106–20.
Lin, Ruitao, Yanhong Zhou, Fangrong Yan, Daniel Li, and Ying Yuan. 2020. “Boin12: Bayesian Optimal Interval Phase i/II Trial Design for Utility-Based Dose Finding in Immunotherapy and Targeted Therapies.” JCO Precision Oncology 4: 1393–1402.
Lin, Xiaolei, and Yuan Ji. 2021. “Probability Intervals of Toxicity and Efficacy Design for Dose-Finding Clinical Trials in Oncology.” Statistical Methods in Medical Research 30 (3): 843–56.
Takeda, Kentaro, Masataka Taguri, and Satoshi Morita. 2018. “BOIN-ET: Bayesian Optimal Interval Design for Dose Finding Based on Both Efficacy and Toxicity Outcomes.” Pharmaceutical Statistics 17 (4): 383–95.