Cancer decentralized clinical trials in the Veterans Health Administration.

BACKGROUND: Despite the importance of clinical trials in the advancement of cancer treatments, there are barriers to participant enrollment. Decentralized clinical trials are conducted at a different physical location than where patients receive medical care and can address patient-level and institution-level barriers that affect participant enrollment. METHODS: The Veterans Health Administration (VA) created a cancer-focused decentralized clinical trial program with a dedicated research team, operational manual, and other standardized operational protocols to support trial conduct. The decentralized clinical trial program works closely with the VA Office of Research & Development and VA central institutional review board. RESULTS: Ten cancer decentralized clinical trials have been implemented: 2 observational, 5 nontherapeutic interventional, and 3 therapeutic interventional. Eight were implemented as fully remote decentralized clinical trials, and 2 were hybrid decentralized clinical trials, with hybrid requiring collaboration with local clinicians for nonresearch activities. Across 47 VA medical centers, 134 Veterans enrolled: 31 (23%) in observational, 99 (74%) in nontherapeutic interventional, and 4 (3%) in therapeutic interventional decentralized clinical trials. Demographic characteristics of enrolled participants mirrored that of Veterans receiving cancer care through the VA's National TeleOncology service, including rurality (31%) and non-White minority status (19%). Examples of the methods for research conduct that have been used across these decentralized clinical trials are included. CONCLUSIONS: Cancer decentralized clinical trials can address barriers to participant enrollment, but not every clinical trial can be conducted in a decentralized manner. By sharing experiences regarding the conduct of cancer decentralized clinical trials in the VA, research sponsors, regulatory authorities, and other research groups can more readily and widely implement these trials.

Duke Scholars

Author Daphne Ruth Friedman Medicine, Medical Oncology

Author Michael John Kelley Medicine, Medical Oncology