Lecture Time: July 30, 2024 (Tuesday) 10:00-11:30

Venue: Emerald Science and Education Building, Block B, Room 1710

Speaker: Associate Professor Yong Zang

Affiliation: Indiana University School of Medicine

Hosted by:School of Mathematics

Abstract:

In the early phase development of molecularly targeted agents (MTAs), it is common to expect that an MTA will be more effective for a specific biomarker subgroup, such as marker-positive patients. However, there may not be sufficient evidence to prove that the MTA is ineffective for the other subgroup, namely, marker-negative patients. Once it is established that marker-positive patients benefit from the treatment, it becomes clinically important to determine whether this benefit also extends to marker-negative patients. To address this practical issue in phase II clinical trials, we propose a series of adaptive biomarker-guided designs. These designs can be implemented with or without the inclusion of a randomized control treatment. The proposed designs initially evaluate the treatment effect in marker-positive patients and subsequently assess marker-negative patients if necessary. Multiple interim analyses are incorporated to allow early termination of the trial if the MTA is found to be either futile or superior. Simulation studies indicate that the proposed adaptive designs perform well and are ethically more favorable compared to commonly used designs.

Speaker's Profile:

Dr. Yong Zang is the Indiana University School of Medicine Showalter Scholar Associate Professor. He also serves as the Co-Director of Clinical Research for the Biostatistics and Data Management Core, IU Simon Comprehensive Cancer Center. He received his Ph.D. degree from The University of Hong Kong and finished his Postdoctoral training in The University of Texas, MD Anderson Cancer Center. His research interests are clinical trial design and statistical genetics. He has published over seventy papers in peer-reviewed statistical, genetics and medical journals such as Biometrics, Biostatistics, JRSSC, American Journal of Human Genetics, Genome Research, Cancer Research and Clinical Cancer Research. His research is supported by National Institute of Health, Showalter Trust and Indiana CTSI.