Basket protocol« Back to Glossary Index
A basket protocol is a type of master protocol designed to test a single investigational therapy or therapy combination in patients from different disease groups or subgroups in the same clinical trial. The populations in the different “baskets” may be defined by disease, disease stage, histology, number of prior therapies, genetic variants, other biomarkers, or demographic characteristics (such as age). Basket trials may allow new drugs to be tested and approved more quickly than traditional clinical trials.
National Cancer Institute (NCI) Dictionary of Cancer Terms
U.S. Food and Drug Administration (FDA): Master Protocols: Efficient Clinical Trial Design Strategies To Expedite Development of Oncology Drugs and Biologics
Basket Clinical Trial Designs: The Key to Testing Innovative Therapies is Innovation in Study Design and Conduct (Association of Clinical Researchers, 2020)