Seminar by Dr. Yong ZANG from Department of Biostatistics and Health Data Science, Indiana University

A generalized phase 1-2-3 design, Gen 1-2-3, that includes all phases of clinical treatment evaluation is proposed. The Gen 1-2-3 design has the following key features. In stage 1, it uses phase 1-2 criteria to identify a set of candidate doses rather than one dose. In stage 2, which is intermediate between phase 1-2 and phase 3, it randomizes additional patients fairly among the candidate doses and an active control treatment arm and uses survival time data from both stage 1 and stage 2 patients to select an optimal dose. It then makes a Go / No Go decision of whether or not to conduct phase 3 based on the predictive probability that the selected optimal dose will provide a specified substantive improvement in survival time over the control. A simulation study shows that the Gen 1-2-3 design has desirable operating characteristics.

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 Department of Statistics and Actuarial Science, 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.