Speaker: Dr. Yimei Li from St. Jude Children’s Research Hospital
Date and Time: Friday, April 30, 2021, 11am – 12pm via Zoom. Please contact Qingning Zhou to obtain the Zoom link.
Title: Group sequential design for historical control trials using error spending functions
Abstract: Randomized clinical trials (RCTs) are considered the gold standard for clinical trials comparing treatment groups. However, historical control trials (HCTs) are an alternative to RCTs if randomization is not feasible because of ethical concerns, patient preference, limited patient populations, or regulatory acceptability. The major benefit of HCTs is that all patients can receive the new treatment with historical data providing the information for the control arm. Therefore, HCTs are useful for studies with limited patient populations. Group sequential designs using Lan-DeMets error spending functions are proposed for historical control trials with time-to-event endpoints. Both O’Brien–Fleming and Gamma family types of sequential decision boundaries are derived based on sequential log-rank tests, which follow a Brownian motion in a transformed information time. Simulation results show that the proposed group sequential designs using historical controls preserve the overall type I error and power. An example is provided to show how to use the method to design a Children Oncology Group High Grade Glioma trial.