Help to improve the equity of clinical trials by providing site-level participant demographic data including race, sex, age and ethnicity has been revealed.
Medidata, a Dassault Systèmes company, has launched the intelligent trials diversity module.
The new 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.
Disproportionate
Medidata says this insight will help bring diversity into the beginning of the feasibility process, all while accelerating trials. Historically, it adds, 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 disease and lung cancer trials, two diseases that disproportionately affect black Americans.
Fareed Melhem, senior vice president, at Medidata AI, said: “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.
“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.”
Measures of diversity
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 research on clinical trial site diversity, based on a sample from more than 28,000 clinical trials across indications and more than 8.5 million patients, is available in the 2022 ASCO Quality Care Symposium abstract titled “How granularity of data matters in understanding and accelerating racial diversity in U.S. clinical trials,” and in a newly released white paper, “The State of Black Participation in Clinical Trials.”
The white paper is the first of a series, with future reports to focus on additional measures of diversity beyond race, such as sex, age, and ethnicity. Medidata’s new intelligent trials offering supports the U.S. Food and Drug Administration (FDA) draft guidance to industry, which makes a strong call to action for the enrollment of more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials.
Race data
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 1-3 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.