TITLE: Sequential monitoring of adaptive randomized clinical trials
INSTRUCTOR: Hongjian Zhu, AbbVie Inc.


Clinical trials are intricate endeavors with multiple objectives, including controlling the type I error rate, enhancing the power to detect treatment differences, allocating more patients to superior treatments, achieving balance in covariates across treatments, and more. To fulfill these objectives, the literature proposes two distinct families of techniques: (i) the analysis approach—where observed data is analyzed sequentially, and (ii) the design approach—where the allocation probability is altered sequentially. Sequential monitoring has administrative, ethical, and economic advantages. Response adaptive randomization (RAR) can also achieve ethical and efficient objectives by skewing the allocation proportion. In addition, it is well known that an imbalance of the confounding covariates across treatments may bias the study results. This imbalance can be mitigated by covariate adaptive randomization (CAR). CAR can also reduce the selection bias, minimize the accidental bias, and improve statistical efficiency. This tutorial delves into the fundamentals of sequential monitoring, responses adaptive randomization, and covariate adaptive randomization. Additionally, we present theoretical and numerical findings from sequential monitoring in various adaptive randomized clinical trials.

Instructors’ Biography:

Dr. Hongjian Zhu received his Ph.D. in Statistics from the University of Virginia in 2010 and subsequently completed postdoctoral training at Yale University in 2012. Then he joined UTHealth and was promoted to tenured Associate Professor. Currently, he is a Director in the Statistical Innovation Group at AbbVie Inc. In this role, he offers strategic, innovative thinking and develops novel statistical methodology for various Therapeutic Areas, including Immunology, Oncology, and Eyecare. His primary research focuses on adaptive clinical trial designs. He has published papers in top-tier journals such as The Journal of the American Statistical Association (JASA), The Annals of Statistics, Biometrics, The Journal of the American Medical Association (JAMA), and The Journals of the American College of Cardiology (JACC). He received funding from the National Science Foundation as the Principal Investigator. He is an Elected Member of the International Statistical Institute (ISI) and president-elect of the Houston Area Chapter of the ASA (HACASA).

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