Enhancing Clinical Trial Diversity and Access in the US

July 17, 2023 - In this episode of Healthcare Strategies, Liz Beatty, co-founder and chief strategy officer at Inato, shared insights on the efforts to enhance clinical diversity and access in the United States. By allowing community research centers to choose the trials that align with their needs and patients, Beatty hopes to revolutionize the clinical trial process.

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According to Beatty, the decision to participate in a clinical trial is significant for patients. “Deciding to participate in clinical trials is a major life decision,” said Beatty. “Access to patients has been on the decline. Only about 5% of patients participate in clinical trials — facilitated by the fact that a small number of sites get selected in trials.”

Enabling patients to stay local with trusted doctors and care teams while still accessing trials can benefit patients and the medical innovation sector.

Beatty also emphasized the importance of considering patient diversity and access in the clinical trial landscape. Using a two-sided platform, Beatty’s organization empowers research sites to determine the right trials rather than waiting for feasibility questionnaires from sponsors.

This innovative approach grants community research centers the agency to participate in trials that align with their unique capabilities and patient populations. By eliminating the need for patients to travel long distances or leave their trusted healthcare providers, barriers to participation are removed, facilitating faster access to medical advancements.

When selecting community sites for clinical trials, Beatty does not impose predetermined factors. Instead, the platform allows sites to assess and decide which trials fit everyone involved. This approach represents a paradigm shift in the industry, where a small number of sites historically dominate trial selection, leading to limited patient access. This model aims to democratize trial participation and empower community research centers to be more significant in advancing medical research.

"Flipping the model will change the dynamics and allow sites to be part of the right trials for them and their patients,” reassured Beatty.

The platform enables sites to showcase their unique capabilities to ensure community sites have the necessary resources and capacity to conduct clinical trials effectively. Through a matching process and close collaboration, Beatty’s organization helps sites understand trial requirements and determine if they are a good fit. This streamlined approach saves time for sites, making the process more efficient and effective.

For Beatty, addressing language and cultural barriers that affect participant recruitment and retention at community sites is a priority. By working closely with sites to understand their specific patient populations, language capabilities, and community outreach efforts, community sites can effectively enroll underrepresented patients, supporting diversity and inclusion in clinical trials.

While many trials traditionally occur in coastal regions and major metropolitan areas, this platform aims to expand access to rural locations. These centers often already have the necessary processes and mechanisms to support patients who travel long distances.

“With this platform, [healthcare professionals] can move beyond asking patients to fly long distances in the United States to participate in trials by only going to major academic centers,” Beatty explained.

Beatty notes that training community sites in trial protocols, data collection, and adverse event reporting and ensuring they have the necessary expertise is critical. Through an iterative process, assessed site capabilities are evaluated and matched with appropriate trials.

"What we've learned from sites is that they dedicate significant time to trial searching. By streamlining the process and presenting the right trial at the right time through the matching platform, the efficiency and effectiveness of these sites can be greatly enhanced," concluded Beatty.