New Data Links Decentralized Clinical Trial Approaches to Improved Diversity in Patient Populations

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Medable has shared new data from the Tufts Center for the Study of Drug Development (CSDD)’s PACT Consortium linking decentralized clinical trial (DCT) approaches to a higher rate in participation across multiple demographic groups. The new research shows that a more strategic implementation of DCT elements, combined with increased regulatory oversight, can meaningfully improve diversity in clinical research.¹

In a press release, Ken Getz, MBA, executive director and research professor, Tufts CSDD, Tufts University School of Medicine, said, “It is important to look carefully into the variability of the data. Increasing diversity in clinical trials requires a multifaceted approach rather than a monolithic one. In our research, we see certain decentralized elements, like local labs, can dramatically boost enrollment among Black participants so you must be intentional when applying DCT solutions. It’s not one size fits all.”

The research from the PACT Consortium analyzed 69 clinical trials and showed 20.9% of participants identified as Asian in DCT‐enabled trials compared to only 14.2% in more traditional trials, and enrollment of American Indian or Alaska Native participants was nearly quadruple (1.9% versus 0.5%). Additionally, female representation rose significantly from 49.0% to 55.7%. Despite significant improvements in these populations, Black or African American participants represented just 7.3% of clinical trial enrollees, even with DCT approaches in place.

In the press release, Pamela Tenaerts, MD, MBA, chief scientific officer, Medable, and a founding member of the PACT Consortium, added, “The first year we focused on creating consensus on definitions and gathering as many trials as possible—now, close to 70—and hope to double that next year. Medable is fiercely committed to investing in evidence-generation on the impact of decentralized elements on clinical trials so we can uncover the indisputably best ways to apply technology to make a significant impact on research. PACT members already want to add more variables to test—it’s like peeling an onion. Every time you pull back a layer, you find new dimensions to explore.”

Earlier in June 2024, Applied Clinical Trials spoke with Tenaerts about her initial reaction to the FDA releasing its Diversity Action Plan guidance, which has the potential to increase diversity in clinical research even more alongside decentralized approaches.

“It was awaited, so we're all happy it came out and I think it's going in the right direction. I think they lay out a logical plan for why this is important and how this should be done, and what you could potentially do to achieve diversity. To bring it back to why this is important, we need to have trials that reflect the intended population,” she said.

The PACT Consortium is managed by Tufts CSDD and backed by over 30 top‐tier pharmaceutical organizations and technology providers, including Medable. Key contributors of financial resources and frontline insights from clinical trials include AbbVie, Amgen, Gilead, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, GSK, Janssen, Novartis, Pfizer, Roche Genentech, and Sanofi. The consortium is also backed by the NIH, FDA, and National Cancer Institute, which all provide additional oversight and expertise.

Reference

1. New Data Reveals Decentralized Clinical Trials Linked to Improved Diverse Participation Across Many Underrepresented Demographics. Medable. News release. January 28, 2025. Accessed January 29, 2025. https://www.businesswire.com/news/home/20250128743171/en/New-Data-Reveals-Decentralized-Clinical-Trials-Linked-to-Improved-Diverse-Participation-Across-Many-Underrepresented-Demographics