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Patients Most In Need Face Obstacles to Participating in Life-Saving Clinical Trials According to a New Milken Institute Report

The report is part of the think tank’s expanded work to increase access to and diversity in clinical trials

Clinical trials can provide the possibility to obtain novel treatments for conditions and diseases that are not yet commercially available. Yet, these lifesaving treatments are often difficult or impossible to reach due to the physical distance to the clinical trial site. This is especially true for people in rural parts of the country. That’s according to a new report by the Milken Institute, Distance as an Obstacle to Clinical Trial Access: Who is Affected and Why It Matters.

The report highlights how clinical trials, which predominate in major metropolitan areas on the coasts, are often far away from the patients who would benefit the most from participation, leading to poorer health outcomes. The report’s authors map the highest prevalence locations for certain diseases and chronic conditions that are also prohibitively far. These high-prevalence, low-access locations are high-priority places for innovations such as decentralized clinical trials.

“Very few Americans are ever approached to participate in clinical research studies and this report demonstrates that the lack of sufficient infrastructure creates a major gap in our ability to engage research participants in all the places where they live, work, shop, and get their care,” said Esther Krofah, executive vice president of Health at the Milken Institute.

The report explores the distribution of clinical trials and includes an accompanying interactive map, highlighting data that shows where distance is prohibitive to access to clinical trials. The footprint of distance as a barrier differs from disease to disease, even when diseases have similar nationwide prevalence.

“This report provides detailed, actionable intelligence on where to deploy trial resources such that they will make large improvements in terms of patient access,” said Andrew Friedson, director of health economics at the Milken Institute, a co-author of the report. “We highlight where trials are not, and where high-prevalence populations are. Put those together and you have your highest return locations if you are trying to knock down distance as a barrier to access.”

For example, there are large clusters of counties with high prevalence of diabetes but also a large travel distance to the nearest clinical trials in New Mexico and Appalachia. A similar cluster exists for Alzheimer’s disease and related dementias in Texas, Oklahoma, and Kansas. Increasing representation of those who live far from clinical trials has an equity component as well: places far from clinical trials have higher poverty rates, lower rates of health insurance, and a larger proportion of their population is civilian veterans than places that are close to clinical trials.

“This means that solutions that improve access will need to be customized to the locations and the populations that they serve,” added Friedson.

The new report is part of a broader effort by the Milken Institute FasterCures to increase access to and diversity in clinical Trials. The think tank with partner organizations recently released Toward a National Action Plan for Achieving Diversity in Clinical Trials and launched Enabling Networks of Research Infrastructure for Community Health through Clinical Trials (ENRICH-CT), a multi-stakeholder initiative focused on driving dialogue and advancing practical solutions for ways the public and private sectors can support more infrastructure in the US for more inclusive clinical research.

ENRICH-CT has already grown to include more than two dozen founding members across academia, government, nonprofit, and private industry. Several founding members were in attendance today at the EY, Yale + Bioethics International’s Annual Pharmaceutical Executive Roundtable on Bioethics, Social Responsibility, Health Equity + the Role of Pharma: Metrics for Success, where Krofah participated in a panel discussion, highlighting the newly released report and how its findings reinforce the work of the ENRICH-CT partnership.

“Through our ongoing work at FasterCures and ENRICH-CT, we are finding new ways to partner, collaborate, and help forge solutions to prevent diseases and improve health outcomes,” said Krofah. “This report supports these efforts, where we are advancing a path forward to a national clinical research infrastructure that serves the needs of the future, and a demographically diverse population in the US.”

More information about FasterCures, ENRICH-CT can be found here or by writing to ENRICH-CT@milkeninstitute.org.

About the Milken Institute

The Milken Institute is a nonprofit, nonpartisan think tank focused on accelerating measurable progress on the path to a meaningful life. With a focus on financial, physical, mental, and environmental health, we bring together the best ideas and innovative resourcing to develop blueprints for tackling some of our most critical global issues through the lens of what’s pressing now and what’s coming next. For more information, visit www.milkeninstitute.org.

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