New Tech Helps Improve Clinical Trial Diversity, Inclusion

Medidata, a Dassault Systèmes company, has launched the Intelligent Trials Diversity Module to help improve the equity of clinical trials by providing site-level participant demographic data including race, sex, age, and ethnicity. The new Intelligent Trials Diversity Module will help sponsors and clinical research organizations (CROs) benchmark the diversity of their trials and identify sites that are more successful at enrolling diverse patients. This insight will help bring diversity into the beginning of the feasibility process, all while accelerating trials.
 
Historically, clinical trials have been shown to recruit disproportionately white participants, which raises concerns about the generalizability of trial results to underrepresented patients. New Medidata research* shows that in the past decade 70% of sites did not enroll a single Black participant in Alzheimer’s and lung cancer trials, two diseases that disproportionately affect Black Americans.
 
“Powering greater diversity is critical for our industry and a priority for Medidata. With this new offering, it is now possible to identify high-performing sites known to recruit diverse patients. This supports more representative outcomes, and promotes much needed equity within clinical research,” said Fareed Melhem, senior vice president, Medidata AI. “By providing our standardized and analysis-ready demographic and operational data in a study’s planning stages, sponsors and CROs can optimize planning and diversity performance from the start.” 
 
Medidata’s Intelligent Trials brings together cross-industry real-time performance metrics, predictive models, and forecasting capabilities to provide a competitive edge in trial planning and execution. With the addition of the Diversity Module, sponsors and CROs can set goals by benchmarking diversity at the study level in the same indication. The new offering will also identify sites that are more successful at recruiting and enrolling diverse individuals based on industry data.
 
Medidata’s new Intelligent Trials offering supports the U.S. Food and Drug Administration draft guidance to industry, which makes a strong call to action for the enrollment of more participants from underrepresented U.S. racial and ethnic populations into clinical trials. Legislation like the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act, which would mandate the inclusion of diverse populations, also shows the importance for the industry to address this critical issue.
 
*The sample included closed-enrollment, interventional, Phase I-III trials from 2010 to 2021 where race data was collected – encompassing 972,773 patients and 4,003 global trials.
 
Medidata is a wholly owned subsidiary of Dassault Systèmes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value. 
 
Dassault Systèmes, the 3DEXPERIENCE Company, is a catalyst for human progress, providing business and people with collaborative 3D virtual environments to imagine sustainable innovations. By creating virtual twin experiences of the real world with its 3DEXPERIENCE platform and applications, customers push the boundaries of innovation, learning and production to achieve a more sustainable world for patients, citizens, and consumers.