Clinical Trial Diversity

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 on the basis of race, ethnicity, age, sex, gender and social determinants of health. This lack of representation significantly hampers our understanding of treatment responses in diverse populations, perpetuating cancer care inequities and resulting in poor outcomes among historically marginalized communities. Although enhancing diversity in clinical trials has long been a focus for sponsors, the FDA's 2022 guidance now mandates sponsors develop diversity action plans, ensuring therapies are tested in representative populations.

To drive the development of diversity plans, the FDA strongly encourages sponsors to harness a range of data sources, including valuable real-world data. Sponsors must possess comprehensive datasets, sufficient time for analysis, effective tools to apply insights in decision-making, and access to sites capable of enrolling a diverse and representative patient population, all in line with the FDA's expectations. Failure to promptly design and execute plans to establish and achieve enrollment goals could result in trial delays, or expensive post-marketing commitments (PMCs) and post-marketing requirements (PMRs).

With a referenceable diversity plan supported by real-world data from community and academic settings, sponsors can effectively fulfill FDA guidance while addressing the needs of regulatory, clinical development, and clinical operations teams. Our solution leverages data derived from diverse 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

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.

Javier is responsible for defining and executing the company’s strategic vision for real-world evidence, providing thought leadership and guidance around novel clinical research methods, and partnering with clients and stakeholders across academia, life sciences and government agencies to further the use of real-world data. Prior to Flatiron, Javier led the Real World Evidence and Late Phase business at Syneos Health and is a MD and Epidemiologist by training with prior roles at Sanofi and AstraZeneca.