Umbrella protocol« Back to Glossary Index
An umbrella protocol refers to a type of master protocol designed to evaluate multiple investigational therapies administered as single drugs or as drug combinations in a single disease population. Umbrella trials can employ randomized controlled designs to compare the activity of the therapy being studied with a common control arm. The therapy chosen as the control arm for the randomized substudy or substudies should be the standard of care (SOC) for the target population. Thus, the control are may change over time if newer therapies replace the SOC.
U.S. Food and Drug Administration (FDA): Master Protocols – Efficient Clinical Trial Design Strategies To Expedite Development of Oncology Drugs and Biologics