The Superiority of the Time-to-Event Continual Reassessment Method to the Rolling Six Design in Pediatric Oncology Phase I Trials

摘要

BackgroundThe Rolling Six Design (RSD) is currently being used by the Children’s Oncology Group (COG) as their standard design for Phase I trials. Because the COG has large multi-center trials with fast accrual, the motivation for adopting the RSD is to hasten accrual and shorten the duration of their trials. However, trial suspension due to completion of follow-up still cannot be entirely avoided by the RSD. Therefore, a design that allows continuous enrollment of patients throughout the entire trial is needed.