Statistical Considerations in the Design and Analysis of Basket and Umbrella Trials (306508)*Laura M Yee, National Cancer Institute
Keywords: master protocols, precision medicine, basket trials, umbrella trials, oncology
Basket and umbrella trials have become common in the field of oncology where precision medicine is the new frontier. In these trials, patients are often screened with a molecular assay to be assigned to different substudies and therapies. What is the difference between a basket trial and an umbrella trial? How is the molecular assay (or set of assays) chosen? What are the unique statistical challenges in these trials? In this introduction to basket and umbrella clinical trials, these questions will be elucidated with examples from research in the field of oncology.