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Standard and Adaptive Designs for Phase I Clinical Trials

September 16, 2020 @ 12:00 pm - 1:00 pm

Nelson Chen close up with face in focus and book shelves on background.
Nelson Chen close up with face in focus and book shelves on background.

Zhengjia (Nelson) Chen, PhD

Director, Biostatics Shared Resources
UI Cancer Center
Associate Professor, Division of Epidemiology and Biostatistics, School of Public Health, UIC

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In this seminar, I will begin with introducing this series of Biostatistics and Bioinformatics seminars and the newly established Biostatistics Shared Resource (BSR) of UICC. Then I will talk about the classification of clinical trials by phase and their purpose. As the standard Phase I clinical trial designs, the Standard 3+3 designs will be elaborated and a publication with its application will be discussed. Adaptive Phase I clinical trial designs are the key ways to improve clinical trial practice and achieve precision medicine, therefor I will introduce the theory and application of the two typical adaptive Phase I designs, Continuous Reassessment Method (CRM) and Escalation with Overdose Control (EWOC). My publication of a completed trial using EWOC will be presented and discussed. At last, I will briefly introduce 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. To facilitate the application of our novel Phase I designs, we have also developed the corresponding statistical software and R-packages.


September 16, 2020
12:00 pm - 1:00 pm
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