Asian participation increased by 6 percentage points; American Indian/Alaska Native participation quadrupled; Female participation rose from 49.0% to 55.7%
New Data Reveals Decentralized Clinical Trials Linked to Improved Diverse Participation Across Many Underrepresented Demographics
Media Contact:
Lisa Barbadora, Barbadora INK for Medable
+1 (610) 420-3413
lbarbadora@barbadoraink.com / media@medable.com
Medable Inc., a leading provider of clinical development technology, today announced new data from the Tufts Center for the Study of Drug Development (CSDD)’s PACT Consortium links decentralized clinical trial (DCT) approaches to notably higher participation rates across multiple demographic groups. The new research shows that a more strategic implementation of DCT approaches in conjunction with more regulatory rigor, such as the US FDA Diversity Action Plan requirement, can meaningfully shift diversity metrics in clinical research.
The analysis, covering 69 clinical trials, 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%). Female participation also rose significantly from 49.0% to 55.7% and is more representative with the total U.S. population, according to 2023 Census Bureau data. However, Black or African American participants still represented just 7.3% of clinical trial enrollees, even with DCT approaches in place, compared with their representation of 14.9% in the total U.S. population.
“It is important to look carefully into the variability of the data,” said Ken Getz, Tufts CSDD Executive Director and research professor. “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 PACT Consortium – managed by Tufts CSDD and backed by over 30 top?tier pharmaceutical organizations and technology providers including Medable – seeks to provide the industry with a data?driven blueprint for action. AbbVie, Amgen, Gilead, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, GSK, Janssen, Novartis, Pfizer, Roche Genentech, and Sanofi contribute financial resources and frontline clinical insights, while the NIH, FDA, and National Cancer Institute provide additional oversight and expertise.
“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,” said Dr. Pamela Tenaerts, Medable Chief Scientific Officer, and a founding member of the PACT Consortium. “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.”
Tenaerts and Getz will be available at the 2025 SCOPE event in Orlando, FL, booth #717, to discuss these early results and continued research of the PACT Consortium. Medable will also be presenting with Christina Fawcett, Director of Digital Health Delivery at GSK, on the importance of control during study launch on Wednesday, Feb. 5 at 9:55am.
Medable has deployed its software-as-a-service platform in more than 300 decentralized and hybrid clinical trials in 70 countries, serving more than one million patients and research participants globally. Customers have achieved impressive results – including 90% eCOA adherence and 50% cost reductions. A Tufts CSDD study also shows that, on average, decentralized trials can achieve net financial benefits from five to 13 times for Phase II and Phase III trials, equating to roughly $10 million ROI and $39 million ROI for an investment on average of $500K in Phase II and $1.5M in Phase III trials, respectively. Recently, the company launched Medable AI and Medable Studio to automatically convert outcomes assessments into fully digital eCOAs in seconds – now accessible on Google Cloud Marketplace.
About Medable
Medable is on a mission to get effective therapies to people faster. Its digital clinical trials platform enhances speed, scale, and patient access in clinical research, accelerating medicines for thousands of conditions without treatment or cure. Awarded Best Digital Health Solution by the Galien Foundation, Medable’s platform has been deployed in nearly 400 trials in 70 countries and 120 languages, serving more than one million patients globally. Medable is a privately held, venture-backed company headquartered in Palo Alto, California, and was listed for the second year in a row on the Inc. 5000 in 2024.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250128743171/en/
