Medidata, a Dassault Systèmes company, announced the launch of the Medidata Diversity Program, the industry’s most comprehensive solution for improving diversity, equity, and inclusion in clinical trials.
The Medidata Diversity Program supports biopharmaceutical and medical device companies and clinical research organizations (CROs) by addressing common systemic and clinical barriers that can hinder a diverse range of individuals from participating in clinical trials. By combining capabilities across Medidata AI and Medidata Patient Cloud portfolios, the program creates a novel and unique approach to achieving diversity throughout the clinical trial process by improving awareness and experiences for patients, streamlining access to trials, enabling decentralization, and supporting data-driven decision-making needed to execute the modern diversity action plans required for regulatory success.
This landmark launch coincides with increasing dialogue among industry leaders and regulators about the need for greater diversity throughout the clinical trial process. Historically, clinical trials have recruited predominantly Caucasian participants, rather than being representative of the patient populations most affected by the disease. These blind spots can lead to a lack of understanding about how treatments may affect different populations and create inequitable access to treatments that complicate data accuracy and the path to future clinical development.
The U.S. Food and Drug Administration (FDA) indicated that achieving greater diversity in clinical trials will be a key focus for regulators to help evaluate new treatments and methods – especially in therapeutic areas that are known to disproportionately impact diverse communities. The FDA’s latest Draft Guidance on Diversity Plans aims to improve enrollment of underrepresented populations in clinical trials by encouraging investigators and sponsors to create a framework to define and meet specific diversity goals.
“Facilitating more diverse participation in clinical trials is a critical and complex challenge, not only for the life sciences industry but for the patients and caregivers participating in the trials,” said Anthony Costello, Chief Executive Officer, Patient Cloud, Medidata. “The Medidata Diversity Program, the most comprehensive solution to date, will help sponsors and CROs move from awareness about a diversity challenge to planning and solving for it as a standard and sustainable part of their clinical development programs.”
The Diversity Program comprises a suite of innovative and industry-leading solutions including Medidata AI Intelligent Trials, myMedidata Registries and eConsent, the Medidata Patient Insights Program, and Medidata’s partnership with Circuit Clinical – a national network of sites focused on diverse patient populations with localized investigators, trained on Medidata decentralized clinical trial technology. Designed to embed diversity into every aspect of the process, this program positions Medidata as a catalyst for cultivating diversity, closing disparities, and achieving true clinical trial success.
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.
