Fortrea 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. The company'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. 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.