Abstract 919: Veterans Health Administration: Decentralized clinical trials
Authors: Press Ashlyn , Ordman Jennifer , Boreland Jacqueline , Burningham Zachary , Schoenborn Shelby , Stewart Tiffany , Oberg Bethany , Pepperman Perri , Morris Holly , Bloemers Sarah , Kutub Nawshin , Elam Shannon , Kelley Michael J. , Friedman Daphne 
Published: March 2024

Abstract
Purpose: The Veterans Health Administration (VA) created National TeleOncology (NTO) service in 2019 to provide telehealth cancer care to Veterans and to augment care provided at VA facilities through a hub and spoke model. More recently, VA established a Decentralized Clinical Trials (DCTs) infrastructure to support clinical trials (CTs) that rely on telehealth, where research staff are at different locations, and/or where a single IRB provides oversight even when subjects are at different locations.
Brief Description: Research support and infrastructure is variable across VA facilities resulting in uneven access to cancer CTs in the VA system. Veterans often live in rural areas or have transportation challenges, which are barriers to participate in CTs. The COVID-19 pandemic resulted in increased telehealth use in clinical care and in CTs, providing the rationale for a focused effort in DCTs. DCTs have the potential to reduce barriers to CT involvement at the facility- and patient-level and may be more representative of real-world clinical scenarios.
Summary of Data: Since its inception, NTO has provided hematology and oncology telehealth care to over 10,000 Veterans, of which 47.5% live in rural or highly rural areas, 76.5% are white and 13.2% are black or African American. Because the NTO program provides clinical care via telehealth modalities, patients who receive care through NTO may be more comfortable with participating in CTs that use telehealth, and thus are part of a pool of potentially eligible subjects.Since creation of the DCT program, three cancer DCTs have been conducted in the VA (1) BNT001 Digital Therapeutic Feasibility Pilot Study, (2) Cemiplimab Survivorship Epidemiology (CASE) Study, and (3) Proof-Of-ConcepT DEcentralized CliNical TrIAL (POTENTIAL) study. The BNT study enrolled 24 Veterans, 19 were male, 22 were white, 13 lived in rural areas, and the median age at enrollment was 68 years, including numerous cancer diagnoses. Veterans enrolled in the BNT study received cancer care at seven VA facilities. The CASE study has enrolled 24 male Veterans, 23 were white, 5 lived in rural areas, and the median age at enrollment was 74 years. The POTENTIAL study enrolled 4 male Veterans, 3 were white, 2 lived in rural areas, and the median age at enrollment was 72 years. Upcoming DCTs will focus on the following disease types: metastatic non-small cell lung cancer, multiple myeloma, and relapsed/refractory diffuse large B-cell lymphoma.
Conclusions: The VA provides clinical cancer care to Veterans through the NTO program. The DCT program builds upon the existing clinical infrastructure to conduct CTs on a national scale. The NOP DCT team is a component of the VA’s Enhance Equity and Access to Clinical Trials (ENACT) initiative, which is part of Cancer Moonshot. The DCT program intends to expand CT opportunities to Veterans with cancer, minimize barriers to CT activation and enrollment, and improve access to cancer CTs for all Veterans.
Citation Format: Ashlyn Press, Jennifer Ordman, Jacqueline Boreland, Zachary Burningham, Shelby Schoenborn, Tiffany Stewart, Bethany Oberg, Perri Pepperman, Holly Morris, Sarah Bloemers, Nawshin Kutub, Shannon Elam, Michael J. Kelley, Daphne Friedman. Veterans Health Administration: Decentralized clinical trials [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 919.