3/29 – Zhengjia (Nelson) Chen, University of Illinois at Chicago

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Speaker: Zhengjia (Nelson) Chen

Associate Professor, Division of Epidemiology and Biostatistics, School of Public Health, Director of Biostatistics Shared Resource Core, University of Illinois Cancer Center, University of Illinois at Chicago

Title: Novel Adaptive Designs for Phase I Clinical Trials

Abstract: 

In the seminar, I will begin with introducing our newly established Biostatistics Shared Resource (BSR) of University of Illinois Cancer Center (UICC). As novel adaptive designs and utilization of patient’s genomic profile are the key ways to improve clinical trial practice and achieve precision medicine, I will review common Phase I designs, including Standard 3+3 designs, Continuous Reassessment Method (CRM), Escalation with Overdose Control (EWOC), etc. Then, I will take about our several novel adaptive Phase I designs (EWOUC, EWOC-NETS, EWOC-NETS-TITE, EWOC-NETS-COV, etc.) which are motivated by the important issues emerged from the practice of clinical trials. The EWOUC can provide both overdose and underdose control during dose escalation to protect patients and maximize their therapeutic effects. The EWOC-NETS can fully utilize all toxicities instead of only a binary indicator of dose limiting toxicity (DLT) to increase maximum tolerated dose (MTD) accuracy and trial efficiency. The EWOC-NETS-TITE can further allow flexible patient enrollment without waiting period while utilizing partially completed toxicity data to optimize dosage for new patients. The EWOC-NETS-COV can incorporate patient’s genomic profile to estimate personalized MTD which is the first step toward precision medicine. To facilitate the application of our novel Phase I designs, we have also developed the corresponding statistical software and R-packages.