Standard and Adaptive Designs for Phase I Clinical Trials

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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ABSTRACT:

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.