New Technology from Medidata Helps Sponsors and CROs Improve Diversity and Inclusion in Clinical Trials

The Intelligent Trials Diversity Module addresses the critical need to improve access and engagement in clinical trials

NEW YORK, October 13, 2022–(BUSINESS WIRE)–Medidata, a Dassault Systèmes Group company, has launched the Intelligent Trials Diversity Module to improve the fairness of clinical trials by providing site-level participant demographics, including race, sex, age and ethnicity. The new Intelligent Trials Diversity Module will help sponsors and clinical research organizations (CROs) assess the diversity of their trials and identify sites that are most successful in recruiting diverse patients. This information will help bring diversity early in the feasibility process, while accelerating testing.

Historically, clinical trials have been shown to disproportionately recruit white participants, raising concerns about the generalizability of trial results to underrepresented patients. New research from Medidata* shows that over the past decade, 70% of sites have not recruited a single black participant for trials of Alzheimer’s disease and lung cancer, two diseases that significantly affect disproportionately black Americans.

“Fostering diversity is essential for our industry, and it is a priority for Medidata. Thanks to this new offer, it is now possible to identify high-performing sites, known to recruit a variety of patients. This allows for more representative results and promotes much-needed fairness in clinical research,” said Fareed Melhem, senior vice president at Medidata Ai. “By providing our standardized, ready-to-analyze demographic and operational data during the planning stages of a study, we enable sponsors and CROs to optimize diversity planning and performance from the start. »

Medidata Intelligent Trials brings together real-time performance metrics from multiple industries, predictive models, and forecasting capabilities to provide a competitive advantage in trial planning and execution. With the addition of the Diversity Module, sponsors and CROs can set targets by comparing study-level diversity for the same indication. The new offering will also help identify sites that are more successful at recruiting diverse people based on industry data.

Medidata’s research on the diversity of clinical trial sites, based on a sample of more than 28,000 clinical trials in different indications and more than 8.5 million patients, is available in the ASCO summary Quality Care Symposium 2022 titled “How granularity of data matters in understanding and accelerating racial diversity in US clinical trials” States) and in a recently published white paper, “The State of Black Participation in Clinical Trials.” The white paper is the first in a series, with future reports that will focus on additional metrics for diversity beyond race, such as gender, age and ethnicity.

Medidata’s New Intelligent Trials Offering Supports FDA’s Draft Industry Guidance, which Strongly Calls for Action to Recruit More Participants from Underrepresented Racial and Ethnic Groups into State Clinical Trials -United. Legislation such as the US DEPICT Act on Diverse and Equitable Participation in Clinical Trials, which advocates the inclusion of diverse populations, also shows the importance for the industry to address this hot topic.

*The sample included phase I-III interventional trials with limited participation from 2010 to 2021 in which race data were collected, for a total of 972,773 patients and 4003 international trials.

Medidata is a wholly-owned subsidiary of Dassault Systèmes which, with its 3DEXPERIENCE platform, is positioning itself as a leader in the digital transformation of life sciences in the era of personalized medicine with the first end-to-end scientific and commercial platform, covering the steps from research to commercialization.

About Medidata

Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps provide evidence and insights that enable pharmaceutical, biotechnology, medical device, and diagnostics companies, as well as academic researchers, to accelerate value creation. More than 2,000 customers and partners access the world’s most trusted platform of clinical development, commercial and real-world data. Medidata, a Dassault Systèmes group company (Euronext Paris: FR0014003TT8, DSY.PA), is headquartered in New York and has offices around the world to meet the needs of its customers. Find out more at www.medidata.com and follow us on @medidata.

About Dassault Systemes

Dassault Systèmes, the 3DEXPERIENCE company, is a catalyst for human progress. We offer companies and individuals collaborative 3D virtual environments to imagine sustainable innovations. By creating real-world virtual twin experiences with our 3DEXPERIENCE platform and applications, our customers push the boundaries of innovation, learning and production, to achieve a more sustainable world for patients, citizens and consumers. Dassault Systèmes brings value to more than 300,000 customers of all sizes, in all industries, in more than 140 countries. For more information visit www.3ds.com

3DEXPERIENCE, the Compass icon, the 3DS logo, CATIA, BIOVIA, GEOVIA, SOLIDWORKS, 3DVIA, ENOVIA, NETVIBES, MEDIDATA, CENTRIC PLM, 3DEXCITE, SIMULIA, DELMIA, and IFWE are trademarks or registered trademarks of Dassault Systèmes, a ” French European Company (Versailles Trade Register No. B 322 306 440), or its subsidiaries in the United States and/or other countries.

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