Time-to-Event Bayesian Optimal Interval Design to Accelerate Phase I Trials

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
Ying YuanKatherine E Warren

Abstract

Late-onset toxicity is common for novel molecularly targeted agents and immunotherapy. It causes major logistic difficulty for existing adaptive phase I trial designs, which require the observance of toxicity early enough to apply dose-escalation rules for new patients. The same logistic difficulty arises when the accrual is rapid. We propose the time-to-event Bayesian optimal interval (TITE-BOIN) design to accelerate phase I trials by allowing for real-time dose assignment decisions for new patients while some enrolled patients' toxicity data are still pending. Similar to the rolling six design, the TITE-BOIN dose-escalation/deescalation rule can be tabulated before the trial begins, making it transparent and simple to implement, but is more flexible in choosing the target dose-limiting toxicity (DLT) rate and has higher accuracy to identify the MTD. Compared with the more complicated model-based time-to-event continuous reassessment method (TITE-CRM), the TITE-BOIN has comparable accuracy to identify the MTD but is simpler to implement with substantially better overdose control. As the TITE-CRM is more aggressive in dose escalation, it is less likely to underdose patients. When there are no pending data, the TITE-BOIN seamles...Continue Reading

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Citations

Jul 10, 2020·Clinical Pharmacology and Therapeutics·Dean BottinoKarthik Venkatakrishnan
Sep 24, 2020·Journal of Biopharmaceutical Statistics·Jun Yin, Ying Yuan
Sep 15, 2020·JCO Precision Oncology·Ying YuanSusan G Hilsenbeck
Aug 24, 2018·Journal for Immunotherapy of Cancer·Nolan A WagesKatherine S Panageas
Mar 30, 2019·Journal of the National Cancer Institute·Ruitao LinYing Yuan
May 16, 2020·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Cyrus ChargariEric Deutsch
Jul 2, 2019·Journal of Biopharmaceutical Statistics·Ruitao Lin, Ying Yuan
Jan 14, 2021·JCO Clinical Cancer Informatics·Yanhong ZhouYing Yuan
Mar 2, 2021·Hematology/oncology Clinics of North America·Heidi E Kosiorek, Amylou C Dueck
Apr 7, 2021·Contemporary Clinical Trials·Gu MiWei Zhang
Jun 2, 2021·American Society of Clinical Oncology Educational Book·Razelle KurzrockDavid S Hong
Nov 23, 2021·Statistical Methods in Medical Research·Zichun Xu, Xiaolei Lin

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