Implement a comprehensive clinical trial diversity plan that addresses regulatory needs while avoiding risk to trial timelines.
For decades, many groups of individuals have been underrepresented in clinical trials, including racial, ethnic, age, gender, and social groups.
This omission hinders our grasp of how treatments work across different populations, worsening cancer care inequities and outcomes for historically marginalized communities.
The FDA’s 2022 guidance now requires sponsors to create diversity action plans, mandating representative testing for therapies. To facilitate this, the FDA urges sponsors to leverage diverse data sources, emphasizing real-world data. Sponsors need comprehensive datasets, time for analysis, effective decision-making tools, and access to diverse enrollment sites, aligning with FDA standards. Failure to promptly develop and execute these plans could lead to trial delays or costly post-marketing commitments.
With Flatiron’s Evidence Solutions, sponsors can effectively fulfill the FDA’s diversity guidance while addressing the needs of regulatory, clinical development, and clinical operations teams. Our solutions leverage data derived from representative patient populations, at the point of care, offering actionable, accurate insight. Sponsors benefit from Flatiron's extensive site network for enhanced patient population understanding and data-driven site selection, ensuring optimal outcomes.
Because of our rich data and bench of experts across health equity, real-world data, and clinical research, we can uniquely provide a comprehensive solution that supports all stages of a diversity planning journey.
Deep understanding of patient characteristics, patient journey and disease progression/outcomes in cohort of interest across underrepresented populations
Real-time, detailed exploration of exclusion criteria adjustments at the cohort-level, helping sponsors understand the impact of I/E criteria as it relates to diversity goals
Evaluation of a target product profile's positioning and potential to deliver impact across underrepresented populations and to set achievable enrollment goals
Assessment of community sites within the Flatiron network to inform site selection
Determination of necessary actions to support trial enrollment and retention in underrepresented populations
Support of relevant regulatory meetings, with the goal of meeting individual company needs and serving the FDA mandate
Originally published in JAMA Oncology, this paper explores how real-world data can support the design of more representative clinical trials.
See our summaryExplore additional content related to the use of real-world data and its role in improving health equity, featuring Flatiron data and experts.
Flatiron brings together an extensive bench of experts in health equity, real-world evidence, and clinical research. Our experts work with regulatory and academic bodies to ensure we are on the forefront of industry guidance.
Cleo is a nationally recognized and widely published health equity and cancer outcomes researcher, with expertise in health equity research methods and data analytics, clinical trial diversity, and community engagement. In 2019, she was honored as a ‘40 Under 40’ Leader in Minority Health by the National Minority Quality Forum and Congressional Black Caucus. At Flatiron, Cleo leads the development and execution of Flatiron’s company-wide strategy to advance cancer health equity through real-world evidence generation. Cleo earned a PhD in Health Policy from Harvard University.
Olive is a health services researcher with over 10 years of experience in health equity research methods, cancer outcomes research, clinical trial diversity, community engagement, and research on social determinants of health. At Flatiron, Olive serves as subject matter expert and project lead within the Health Equity Research Lab where she contributes to research examining the drivers of inequities in cancer outcomes. Olive holds a PhD in Health Policy and Management from the University of North Carolina at Chapel Hill Gillings School of Global Public Health and an MHS in Epidemiology from the Johns Hopkins Bloomberg School of Public Health.
Talk to us about your goals for ensuring diversity in clinical trials.