Fortrea, a leading global contract research organization (CRO), today announced its comprehensive and integrated solution to improve the diversity and inclusion (D&I) of participants in clinical trials. Fortrea’s D&I solution is designed to expand patient access to participate in clinical trials and address the U.S. Food and Drug Administration (FDA) requirements, under The Food and Drug Omnibus Reform Act, to increase enrollment of underrepresented populations in clinical trials.

Fortrea’s comprehensive process integrates five components of diversity action planning and execution:

• Real-world evidence advisors research relevant real-world data sets to inform diversity planning.
• Regulatory, development and clinical operational experts design the Diversity Action Plan, validate with patient groups and negotiate with regulators.
• Operational teams access multiple data platforms, Fortrea’s Site Advisory Board and technology-enabled solutions to implement the Diversity Action Plan as an integral part of Fortrea’s clinical trial execution.
• Monitoring and reporting are enabled by Fortrea’s exclusive Diversity and Inclusion Study Insights Dashboard, providing actionable data and visualizations for ongoing study management.
• Experienced report technical writers compile data and prepare reports for regulatory submission, with ongoing regulatory support provided as part of the D&I solution.

"Clinical research that reflects a representative population provides better insight into how a potential treatment will work in a real-world setting,” said John Doyle, DrPH, president Fortrea Consulting. "Recent regulatory requirements codify progress over the last few years in biopharma’s approach to improving the inclusion of diverse populations in their development programs. Fortrea’s solution brings deep, real-world data expertise to design D&I plans that are effective and realistic, along with more than 30 years of experience across more than 20 therapeutic areas in trial execution. We also bring a steadfast commitment to D&I, not just in clinical trials but across our entire company as we pursue our purpose of bringing life-changing treatments to patients faster."

Fortrea’s D&I solution incorporates a series of proprietary tools, including epidemiological and feasibility assessments that leverage an exclusive combination of large data sets. The solution also integrates inputs from patient groups to create insights into protocol tolerance and study conduct support requirements in different patient populations across multiple therapy areas and geographies. These insights inform global and local patient recruitment and retention plans to reach under-represented patient populations and address barriers to participation in clinical trials.

“Ensuring the inclusion of diverse patient populations in clinical trials must go beyond a plan, it takes insight and action,” said Mark Morais, chief operating officer, Fortrea. “Because of our comprehensive Voice of Patient program and our collaboration with diverse investigator sites and site networks, we have a deep understanding of what it takes to be successful in reaching populations that have traditionally been under-represented in clinical trials. At Fortrea, we are informed by real-world data, enabled by innovative technologies, and driven by our passion to deliver new therapies for all patients.”