How Real-World Data Is Used to Increase Diversity and Inclusion in Clinical Trials
Author:
Durga Borkar, MD, MMCi
Verana Health Medical Advisor
Ensuring diversity in clinical trials isn’t just a moral imperative; it’s essential for equitable access to medical advancements and for truly understanding how treatments perform across different populations.
In the field of ophthalmology, where diseases such as diabetic retinopathy disproportionately affects certain minority groups, achieving diversity in clinical trials is particularly crucial.
In the field of ophthalmology, where diseases such as diabetic retinopathy disproportionately affects certain minority groups, achieving diversity in clinical trials is particularly crucial. Yet, the reality is that traditional trial designs often fall short in this regard, due to restrictive eligibility criteria, recruitment practices that fail to reach underrepresented communities, and cultural and historical biases that discourage participation.
Verana Health, through its exclusive partnership with the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight), is uniquely positioned to contribute to taking on some of these challenges by leveraging real-world data (RWD) to enhance the diversity and accessibility of clinical trials in ophthalmology. This is especially timely given the recent U.S. Food and Drug Administration (FDA) requirements for Diversity Action Plans, which are now a crucial component of the clinical trial process.
Leveraging RWD from the IRIS Registry for Clinical Trial Diversity
RWD, particularly from comprehensive databases such as the IRIS Registry, plays a critical role in meeting the FDA’s new diversity requirements in clinical trials.
RWD, particularly from comprehensive databases such as the IRIS Registry, plays a critical role in meeting the FDA’s new diversity requirements in clinical trials. The IRIS Registry’s vast repository of ophthalmic data offers unparalleled insights into patient demographics, disease prevalence, and treatment outcomes across diverse populations.
Eligibility Criteria
Traditional eligibility criteria in clinical trials can unintentionally exclude minority groups. By analyzing RWD from the IRIS Registry, researchers can redefine these criteria to be more inclusive, ensuring that the trial population better reflects the broader patient population.
For example, more lenient hemoglobin A1c exclusion criteria in trials for diabetic macular edema could facilitate the recruitment of more Black and Hispanic patients, who are often underrepresented in such studies.
Enrollment Practices
Effective enrollment practices are key to ensuring diversity in clinical trials. The IRIS Registry’s data can identify geographic areas and demographic groups with higher disease prevalence and lower clinical trial participation rates. This information allows sponsors to develop tailored recruitment strategies that are more likely to reach underrepresented populations.
Verana Health’s Site Explorer application further enhances this by providing granular insights into patient demographics at each clinic site, aiding in site selection and ensuring a more diverse participant pool.
Trial Design
The design of clinical trials must consider the logistical and participant-related factors that may limit diversity. RWD from the IRIS Registry can inform these design decisions by highlighting the preferences and barriers faced by different demographic groups.
For instance, data on healthcare access and utilization patterns can help sponsors design trials that are more accommodating to diverse populations, such as by minimizing the frequency of site visits or incorporating telehealth options.
Moreover, when initial trials do not achieve the desired diversity, RWD can support the design of Phase IV studies and post-market surveillance, ensuring that treatment effects and adverse events are studied in larger, more diverse populations.
Increasing Diversity in Clinical Research With RWE: A Path Forward
Enhancing clinical trial diversity is a complex challenge, but one that is essential for the advancement of equitable and effective medical treatments.
By incorporating real-world data from the IRIS Registry into clinical trial design and implementation, Verana Health is paving the way for more inclusive clinical research. To learn more about how to improve diversity in clinical trials, download our white paper.
Let's Accelerate Research Together
To learn more about Verana Health, please fill out the information below and our team will follow up with you as soon as possible.