Cancer decentralized clinical trials in the veterans health administration.

Abstract

BACKGROUND Despite the importance of clinical trials (CTs) in the advancement of cancer treatments, there are barriers to subject enrollment. Decentralized clinical trials (DCTs) are conducted at a different physical location than where patients receive medical care and can address patient- and institutional-level barriers that impact subject enrollment. METHODS The Veterans Health Administration (VA) created a cancer DCT program, with a dedicated research team, operational manual, and other standardized operational protocols to support DCT conduct. The DCT program works closely with the VA Office of Research and Development and VA central institutional review board. RESULTS Ten cancer DCTs have been implemented two observational, five non-therapeutic interventional, and three therapeutic interventional. Eight were implemented as fully remote DCTs and two were hybrid DCTs, with hybrid requiring collaboration with local clinicians for non-research activities. Across 47 VA Medical Centers, 134 Veterans enrolled: 31 (23%) in observational, 99 (74%) in non-therapeutic interventional, and 4 (3%) in therapeutic interventional DCTs. Demographic characteristics of enrolled subjects mirror that of Veterans receiving cancer care through the VA the 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 DCTs are included. CONCLUSIONS Cancer DCTs can address barriers to subject enrollment, but not every CT is appropriate to be conducted as a DCT. By sharing experiences regarding the conduct of cancer DCTs in the VA, research sponsors, regulatory authorities, and other research groups can more readily and widely implement DCTs.