CANCELED: Biostatistics Seminar Series: Keaven M. Anderson, PhD

Title: Design Issues for late-stage Immuno-Oncology trials Abstract: There are several potential concerns in late-stage clinical trials developing therapies focused on aiding the immune system to fight cancer. Subgroup differences driven by biomarkers can drive several concerns, including target population identification and treatment effects that result in crossing hazards or otherwise delayed treatment benefit.  It is not always clear which endpoints or populations are most likely to demonstrate treatment benefit. These factors create a need for designs that can examine multiple hypotheses and maintain strong Type I error control. Timing of analyses tends to be an important issue. Alternatives to current standards applying stratified log-rank statistics and proportional hazards modeling will be discussed.