Diversity & Inclusion in Clinical Trials
Supporting Diversity Action Plans
We can help you meet regulatory requirements and ensure that therapies are developed in a population with demographic characteristics of the intended use population in the real world.
Proven experience
Meet Diversity Action Plan requirements with the team that has completed ~15 % of the drug products and medical device plans submitted to the FDA thus far.
Expert support
Advance your negotiations with regulators for concurrence on your Diversity Action Plan.
Powerful technology
Leverage in-study diversity insights with the Fortrea Diversity and Inclusion Study Insights Dashboard.
Leading the way on Diversity Action Plans
On June 26, 2024, the U.S. FDA’s draft guidance on improving diversity was published: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. This draft guidance is now open for comments through September 26, 2024. Until the final version is published, it replaces the FDA’s previous guidance published in April 2022.
The Fortrea Regulatory Strategy Consulting team closely tracks the U.S. regulatory landscape to understand how other regulatory agencies (e.g., EMA and MHRA) are working to meaningfully improve the diversity of clinical trial participants in global studies.
Creating solutions beyond the plan
We write and support the implementation of Diversity Action Plans that set diversity goals and help eliminate gaps in participation. Throughout your clinical development, we are an extension of your team to support your diversity goals and inclusion practices. With our unique combination of consulting services, mobile and digital capabilities, strong investigator site network and our innovative Diversity and Inclusion Insights Dashboard, we're ready to enable greater patient access and improve healthcare for all.
Upgrade your diversity planning with real-world data
Our experts help you set realistic diversity goals. Diversity planning begins with a thorough epidemiology assessment to determine the prevalence of the disease in the target patient population utilizing real-world data (RWD) and literature. Our experts then consult to understand the requirements, applicability to your program and map out a path forward.
Locate, attract and retain—bringing your plan to life
With access to multiple data platforms, our Site Advisory Board and technology-enabled solutions, our team identifies where diverse patients are located and implements strategies to attract and retain them.
Supporting regulatory interactions
Your Diversity Action Plan is a living document. Throughout a study and a program, we continue to gather metrics, write reports and support your discussions with regulators, as needed.
The Fortrea Diversity and Inclusion Study Insights Dashboard
Leverage powerful, in-study diversity insights and end-of-study reporting
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In-study enrollment monitoring
To help ensure your study is reflective of a real-world population, we provide in-study enrollment monitoring of the predefined demographic and non-demographic characteristics of participants. From study startup through conduct and closeout, our proprietary dashboard can:
- Analyze data by race, age, sex and ethnicity to assist with the identification of population-specific signals
- Enable the assessment of the safety and effectiveness of the study drug based on key parameter profiles of the subjects enrolled
- Review any subject withdrawals and those lost to follow-up cases across different cohorts/sites to refine your retention strategy
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A real-time view of current trends
With powerful, in-study diversity data from the dashboard, you’ll have a real-time view of current trends in your trial so you can:
- Make informed decisions to assess the impact of your Diversity Action Plan
- Adjust your enrollment and retention strategies
- Implement corrective actions
- Generate reports to support ongoing regulatory engagement and filing