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Overcoming Distance and Disparity: Engaging Rural, Research-Naïve Sites in Clinical Trials

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Meeting enrollment targets presents a challenge for almost every clinical trial. Yet, many sponsors miss the opportunity to reach eligible patients in “rural” and under-served geographic areas, which make up about 19% of the total population of the US,1 due to the potential challenges of engaging smaller, potentially research-naive sites.

There remains a gap in clinical trial education, access, and enrollment for patients outside urban centers, particularly in therapeutic areas with highly complex protocols and ultra-specific eligibility requirements like oncology and gastroenterology. In a recent study of 44 phase 2 and 3 oncology clinical trials, only “19.4% of patients (7184 of 36,995) were from rural locations.”2 From the sponsor’s point of view, community and local sites are often dismissed as enrollment options as they tend to have fewer patients overall. To the site, running a clinical trial may seem overwhelming and time-consuming where resources are already constrained. Finally, from the patient’s perspective, challenges in participating in trials can include travel feasibility, financial constraints, and a lack of education or general. 3 4

However, by implementing clinical trials at rural and research-naive sites, patients can gain access to potential treatment options that were previously out of reach.5

At Milestone One, we understand the value of closing the access gap for underserved and diverse populations to increase patient outcomes6 and access to clinical trials. Through our intimate understanding of small and rural sites’ pain points, including financial concerns, time limitations, technology, and staffing shortages,7 we work to eliminate these barriers.

Milestone One focuses on setting up infrastructure at each site through administrative and operational support at no direct cost – so that investigators can focus on what matters most: their patients. This also allows sites and providers to gain experience running trials with less financial risk or the burden of administrative work during start-up. We tailor clinical trial support to each site during the education and startup process, evaluating their skillset, capacity, and need.

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Clinical research is no longer reserved for large institutions. With Milestone One, physicians can confidently enter the research space, provide patients with access to cutting-edge treatments, and foster growth within their facility.

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1 Bharucha, Adil E, Chung Il Wi, Sushmitha Grama Srinivasan, Hyuckjae Choi, Phillip H Wheeler, Jennifer R Stavlund, Daniel A Keller, Kent R Bailey, and Young J Juhn. “Participation of Rural Patients in Clinical Trials at a Multisite Academic Medical Center.” Journal of clinical and translational science, July 12, 2021.
https://pmc.ncbi.nlm.nih.gov/articles/PMC8596068/#:~:text=Conclusions:,and%20urban%20participants%20in%20trials.


2 Unger JM, Moseley A, Symington B, Chavez-MacGregor M, Ramsey SD, Hershman DL. Geographic Distribution and Survival Outcomes for Rural Patients With Cancer Treated in Clinical Trials. JAMA Netw Open. 2018 Aug 3;1(4):e181235. doi: 10.1001/jamanetworkopen.2018.1235. PMID: 30646114; PMCID: PMC6324281.
https://pubmed.ncbi.nlm.nih.gov/30646114/


3 4 Murthy, V. H., Sateren, W. B., Ford, J. G., Haynes, M. A., Gosschalk, A., Eberhardt, M. S., Ricketts, T. C., Probst, J. C., Phillips, C. D., Medicine, I. of, Baldwin, L.-M., Lara, P. N., & Advani, A. S. (2011a, March 31). Rural–urban differences in discussions of cancer treatment clinical trials. Patient Education and Counseling.
https://www.sciencedirect.com/science/article/abs/pii/S0738399111001248


5 Bhatia, S., Landier, W., Paskett, E. D., Peters, K. B., Merrill, J. K., Phillips, J., & Osarogiagbon, R. U. (2022, July 11). Rural-urban disparities in cancer outcomes: Opportunities for Future Research. Journal of the National Cancer Institute.
https://pmc.ncbi.nlm.nih.gov/articles/PMC9275775/


6 Bhatia, S., Landier, W., Paskett, E. D., Peters, K. B., Merrill, J. K., Phillips, J., & Osarogiagbon, R. U. (2022, July 11). Rural-urban disparities in cancer outcomes: Opportunities for Future Research. Journal of the National Cancer Institute.
https://pmc.ncbi.nlm.nih.gov/articles/PMC9275775/


7 Diaz, N. (January 17, 2025). “We have to Rethink Rural Healthcare”: Inside Intermountain’s coalition. Becker’s Hospital Review.
https://www.beckershospitalreview.com/healthcare-information-technology/we-have-to-rethink-rural-healthcare-inside-intermountains-coalition.html

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