September 14, 2023 Webinar
A Gated Group Sequential Design for Seamless Phase II/III Trial with Subpopulation Selection
Jason Liao, PhD
Abstract
Due to the high cost and high failure rate of Phase III trials where a classical group sequential design (GSD) is usually used, seamless Phase II/III designs are more and more popular to improve trial efficiency. A potential attraction of Phase II/III design is to allow a randomized proof-of-concept stage prior to committing to the full cost of a Phase III trial. Population selection during the trial allows a trial to adapt and focus investment where it is most likely to provide patient benefit. In this talk, we propose a gated group sequential design (gGSD) for seamless Phase II/III trial with potential sub-group selection. Combining this with GSD, the proposed gGSD design enables population selection and multiple interim analyses to enable early stopping with dual-primary endpoints such as the PFS and OS in oncology trials. The gGSD design controls the familywise error rate and allows multiple interim analyses to enable early stopping for efficacy or futility. Simulations and an illustrative example suggest that the proposed gGSD has more power and requires less time and resources compared to the group sequential design and adaptive design. It has the potential to save drug development cost and more quickly fulfill unmet medical needs.
Short Bio
Dr. Jason J.Z. Liao is currently Associate Vice President of Biostatistics at Incyte Corporation overseeing over 60 studies including Phases 1/2/3, and is the head of biostatistics for early oncology development. After receiving his Ph.D. in Statistics from The University of Michigan, Dr. Liao has worked in the pharmaceutical industry for over 20 years in different therapeutic areas, about 15 years of which were spent at Merck. He has unique knowledge and experience in different stages of drug development for small molecule drugs, large molecular drugs, vaccines and biosimilars, which enables him efficiently to identify the key end-to-end items. Dr. Liao is also very active in promoting and developing fit-4-purpose and/or more powerful statistical methods and efficient study designs for the problems and applications in drug development. Professionally, Dr. Liao is a Fellow of The American Statistical Association.