Enterprise Optimization Industry Partnership_Increasing Access to Clinical Research RFI_022026.docx

BACKGROUND

The Department of Veterans Affairs (VA) Office of Research & Development (ORD) has several units that function in various areas to advance basic science and clinical research into clinical practice and aims to improve the health and well-being of our nation’s Veterans. One of the current priority areas of VA ORD is to improve access for Veterans to participate in clinical research activities. The ORD Enterprise Optimization Unit (EO) is one of these functional groups and includes both the VA Cooperative Studies Program (CSP) and the Million Veteran Program (MVP).

The CSP is a clinical research infrastructure embedded within the VA healthcare system. The program was established to execute multi-site clinical trials and epidemiological studies within the purview of VA.1,2 The program’s infrastructure has several Coordinating Centers responsible for the planning and conduct of large multi-site clinical trials in the VA. CSP also established a consortium of 20 VA Medical Centers (VAMCs) called the Network of Dedicated Enrollment Sites (NODES) with teams (Nodes) providing site-level expertise and innovative approaches to address challenges to clinical trial execution.3-7 CSP has extensive sponsor experience in working with sites across a variety of sizes, complexity levels, and geographic locations both within the VA healthcare system and internationally which has created a vast repository of institutional knowledge in the program as it relates to site-level study management.

The MVP is a national research program designed to advance precision health care by learning how genes, lifestyle, military experiences, and exposures affect health and wellness. MVP is the world’s largest biorepository of Veteran data linked to a healthcare system with more than 1,000,000 Veterans enrolled and has one of the world’s most diverse cohorts of any genetic research program.

PURPOSE:

The Enterprise Optimization (EO) unit, through CSP and MVP, are issuing this Request for Information (“RFI”) to solicit information to further advance efforts to increase Veteran access to participate in clinical research opportunities. Information collected from this RFI will serve as continued market research for the development of a Collaborative Research and Development Agreement (CRADA) with a Community Partner(s) (CPs), e.g., retail pharmacy locations, community health centers, academic medical centers and facilities, clinical laboratory sites, etc., to accomplish this objective. Such an agreement will detail the resources to be provided by the VA and the CSP and describe the purpose and expected work to be accomplished between the CSP and MVP research teams and the identified CP. CPs with the infrastructure and capacity to operate in rural areas of the United States (or its territories) will be prioritized.

The VA CSP would like to explore the feasibility of establishing community partnerships with community-based locations to serve as additional clinical research study locations for identified CSP clinical trials and/or epidemiological studies. The intent of this effort is to increase the number of research study sites that Veterans have access to for their participation in clinical research. It is anticipated that these CPs will have the necessary infrastructure in place (dedicated clinical research exam rooms, exam rooms, diagnostic tools (e.g., otoscopes, ophthalmoscopes), vital sign monitors, and medical carts, etc. to complete clinical research study visits (enrollment, follow-up) and all research activities associated with those visits (informed consent, data and blood/specimen collection and shipping, study procedures, etc.) and will supplement existing locations that have been traditionally employed as CSP research sites, e.g., VA Medical Centers (VAMCs), Community-Based Outpatient Clinics (CBOCs), etc. Additionally, the selected CP will have infrastructure and locations in United States geographic regions that align with the CSP Network of Dedicated Enrollment Sites (NODES) so that this clinical research network can support the coordination of start-up, operations, and logistics at these sites. CSP Node sites are currently at the following U.S. locations (Ann Arbor, MI; Atlanta, GA; Aurora, CO; Boston, MA, Bronx, NY; Cleveland, OH; Dallas, TX; Los Angeles, CA; Hines, IL; Houston, TX; Long Beach, CA; Madison, WI; Minneapolis, MN; Omaha, NE; Palo Alto, CA; Philadelphia, PA; Portland, OR; Salt Lake City, UT; San Diego, CA; & Seattle, WA).

The MVP is interested in expanding blood collection capabilities to include rural and remote collection facilities not already covered by the MVP footprint. Activities would include 1) CP staff collecting and labeling blood from consented MVP participants (MVP would securely confirm consent has been obtained) and 2) secure shipment of blood specimens to approved VA/MVP facilities.

DESCRIPTION OF DATA:

CSP data includes electronic health record data, study self-reported surveys, genomic data, and data from other approved data sources on CSP participants. Access to individual level coded CSP data is limited to VA researchers and provided within the VA secure computing environment, in accordance with VA regulatory approvals. The developed CRADA will further outline the relevant regulatory requirements for transmission of appropriate data between the CP(s) and VA and establish data transmission efforts that align with VA data security and privacy regulations.

No MVP data beyond what is needed to confirm consent will be available to the CP.

For other important information and tools used for CSP & MVP please visit:

1. https://www.vacsp.research.va.gov/

2. https://www.vacsp.research.va.gov/CSP_Centers/Network_of_Dedicated_Enrollment_Sites_NODES.asp

3. https://www.mvp.va.gov/pwa/

a. MVP background and objectives

b. MVP Publications: https://www.mvp.va.gov/pwa/science

4. https://phenomics.va.ornl.gov/web/

RESEARCH SCOPE:

The goal of this proposed collaboration between the CSP, MVP, and CP is to employ U.S. based Community Partners (CPs), e.g., retail pharmacy locations, community health centers, academic medical centers and facilities, clinical laboratory sites, etc., to serve as clinical research study sites and increase the catchment area of available research study locations that Veterans can access to participate in VA clinical research. The proposed partnership activities will include the following:

1. The identified CP will have locations that will function as clinical research study visit sites for CSP and MVP

2. Research activities include research study participant enrollment and follow-up visits and/or other research activities associated with those visits (informed consent, data and blood/specimen collection and shipping, study procedures, etc.)

REQUIREMENTS:

· Community Partner and project staff must be located in the contiguous United States, or its territories (American Samoa, Guam, the Northern Mariana Islands, Puerto Rico, and the United States Virgin Islands)

· Complete the attached Intake form

HOW TO REPOND TO NOTIFICATION

Email Intake form and attachments to renee.kale@va.gov

NOTES:

CSP and MVP will not return or provide feedback on any submissions, but does reserve the right to further engage with respondents to clarify understanding of submitted content.

CSP and MVP will treat any response to this RFI as source selection sensitive information if identified as such and will protect confidentiality accordingly.

This notice is for information and planning purposes only and is not to be construed as a commitment by the Government nor will the Government pay for information solicited. Respondents may be notified of the results of the evaluation.

REFERENCES

1. Huang, G.D., Ferguson, R.E., Peduzzi, P.N., & O’Leary, T.J. (2010). Scientific and organizational collaboration in comparative effectiveness research: the VA Cooperative Studies Program model. The American Journal of Medicine, 123(12 Suppl 1): e24-31. https://doi:10.1016/j.amjmed.2010.10.005.

2. Burnaska DR, Huang GD, O'Leary TJ. Clinical trials proposed for the VA Cooperative Studies Program: Success rates and factors impacting approval. Contemp Clin Trials Commun. 2021 Jul 9;23:100811. doi: 10.1016/j.conctc.2021.100811. PMID: 34307958; PMCID: PMC8287148.

3. Condon, D. L., Beck, D., Kenworthy-Heinige, T., Bratcher, K., O'Leary, M., Asghar, A., Willis, C., Johnson, M. R., & Huang, G. D. (2017). A cross-cutting approach to enhancing clinical trial site success: The Department of Veterans Affairs' Network of Dedicated Enrollment Sites (NODES) model. Contemporary clinical trials communications, 6, 78–84. https://doi.org/10.1016/j.conctc.2017.03.006

4. Beck, D., Asghar, A., Kenworthy-Heinige, T., Johnson, M. R., Willis, C., Kantorowicz, A. S., Condon, D. L., Huang, G. D., & VA Cooperative Studies Program (CSP) Network of Dedicated Enrollment Sites (NODES) (2020). Increasing access to clinical research using an innovative mobile recruitment approach: The (MoRe) concept. Contemporary clinical trials communications, 19, 100623. https://doi.org/10.1016/j.conctc.2020.100623

5. Johnson, M. R., Raitt, M., Asghar, A., Condon, D. L., Beck, D., & Huang, G. D. (2021). Development and implementation of standardized study performance metrics for a VA healthcare system clinical research consortium. Contemporary clinical trials, 108, 106505. https://doi.org/10.1016/j.cct.2021.106505

6. Johnson MR, Beck D, Sueiro M, Decker M, Newcomb J, Tiktin M, Kiliveros A, Asghar A. Utilization of a structured research site mentorship model to facilitate site performance in a clinical research network. Contemp Clin Trials Commun. 2024 Dec 31;44:101423. doi: 10.1016/j.conctc.2024.101423. PMID: 39897940; PMCID: PMC11782873.

7. Johnson MR, Asghar A, Beck DJ, Kyriakides T, Vincenti MP, Huang GD. Addressing challenges and barriers to rural Veteran participation in clinical research within the Veterans Affairs healthcare system. Contemp Clin Trials Commun. 2025 Apr 1;45:101466. doi: 10.1016/j.conctc.2025.101466. PMID: 40241933; PMCID: PMC12002789.