Innovative adaptive design for immune-oncology trials

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Innovative adaptive design for immune-oncology trials

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

-- Research published on Clinical Cancer Research




Link to the paper: http://clincancerres.aacrjournals.org/content/early/2018/05/16/1078-0432.CCR-18-0246

Time: 9:00 AM - 10:00 AM PDT (12:00 PM - 1:00 PM EST), Friday, March 8th, 2019

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Please RSVP, the registration will be closed on 11:59 PM, March 6th, 2019.


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/de-escalation rule can be tabulated before the trial begins, making it transparent and simple to implement, but is more flexible in choosing the target DLT rate and has higher accuracy to identify the MTD. Compared to 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 better overdose control. A numerical study shows that the TITE-BOIN design supports continuous accrual, without sacrificing patient safety nor the accuracy of identifying the MTD, and therefore has great potential to accelerate early phase drug development.


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Ying Yuan Image

Bio: Dr. Ying Yuan is a Professor in the Department of Biostatistics at the MD Anderson Cancer Center. Dr. Yuan is an internationally renowned researcher in Bayesian adaptive clinical trial design. He has proposed numerous innovative Bayesian adaptive designs for early phase trials, seamless trials, biomarker-guided trials, and basket and platform trials, which are increasingly used in practice. Dr. Yuan is the co-chief of the Adaptive Clinical Trial Design Section at MD Anderson Cancer Center, developing and overseeing novel adaptive clinical trials at the MD Anderson Cancer Center. He published over 140 peer-viewed papers, and wrote book “Bayesian Designs for Phase I-II Clinical Trials” (published by Chapman & Hall/CRC).


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