Advancing Diversity in Clinical Trials
The benefits of research belong to all.
Or so our ideals tell us. Reality tells a different story. Systemic imbalances exclude too many people from trial opportunities on the basis of race, ethnicity, economic status, geography, or other social determinant. The exclusion may not be deliberate, but its effects are dire.
What’s the solution? More complex than any single changemaker can achieve. Drug developers, researchers, clinicians, policymakers, educators, and patient advocates all share the responsibility to achieve our ideals. TriNetX has a role to play. As a research leader, so do you.
Connect with one of our real-world data experts to discuss how TriNetX can guide your DEI efforts into to ground-breaking territories.
The Need for Change
Connecting the Dots
TriNetX Diversity Solutions
Taking Action
The Need for Change
Asian-Americans represent 5.9% of the U.S. population and a mean of 1.6% of all participants in pivotal trials between 2015 and 2019.
Lolic M, Araojo R, Okeke M, Woodcock J. Racial and Ethnic Representation in US Clinical Trials of New Drugs and Biologics, 2015-2019. JAMA. 2021;326(21):2201–2203.
Black Americans make up roughly 12% of the U.S. population and a disproportionate number of new cancer cases. Yet none of the 11 novel drug approvals for cancer in 2022 were based on study cohorts that enrolled more than 8% Black participants.
Center for Drug Evaluation and Research. Drug Trials Snapshots Summary Report 2022.
Latinos represent 17% of the U.S. population and yet only 6-7% of participants in clinical trials.
S. Presch. Health for All of Us: The Importance of Latino Participation in clinical trials and research. UNIDOS US Blog. 6 March 2018.
The destination is in sight, but we haven’t reached it (not yet).
Connecting the Dots
TriNetX Diversity Solutions
The barriers to diversity, equity, and inclusion (DEI) in clinical trials are multifaceted. At TriNetX, we are focused on breaking down barriers across all our solutions.
From our TriNetX LIVE™ platform, real-world data sets, to expert services, we’re focusing our strength on three areas:
Building Inclusive and Representative Protocol Designs
Sound experimental design necessitates representative samples and extends benefits widely. Protocols attuned to diverse patient backgrounds and RWD-informed approaches ensure generalizable results and inclusive trial participation.
Accelerating Diverse Patient Recruitment
By making criteria “real-world ready,” our clinical analysts and study operations leaders connect you to these institutions globally, enabling faster “First Patient In” on a diverse cohort and delivering hope sooner.
Uncovering Critical Differences in Patient Care through Advanced Data Analysis
We use advanced analytics and top epidemiology experts to deeply interrogate real-world data to reveal critical differences in access, treatment, and outcomes.
Turning inclusion criteria into inclusive criteria
Sound experimental design requires that our samples represent the populations we want to understand. Meanwhile, a commitment to patients demands that we extend benefits, if they are discovered, as widely as possible.
Meeting both mandates starts with the right protocol. Study eligibility attuned to the health and experience of today’s patients, representing all backgrounds, let us design trials with more generalizable results. This RWD-informed approach also extends the benefits of participation to those disproportionately excluded by criteria that paint too broad a brush.
TriNetX Solutions
Meeting today’s diverse patients where they are
Our federated network of care institutions do more than contribute rich, de-identified data. They stand ready to collaborate with you on trials. After making your criteria “real-world ready”, let our team of clinical analysts and study operations leaders connect you to these institutions over our global platform.
Get to First Patient In on a diverse cohort faster, so you can deliver hope sooner.
TriNetX Solutions
TriNetX Summit Spotlight: Addressing Research Challenges with Diversity and Inclusion
Going deep into disparities
Natural course of disease. Disease burden. Standard of care. The forms these take are as various as patients themselves. Trends at the population level can quickly fall apart under analysis by cohort, whether defined clinically or demographically. Our rich de-identified data—inclusive of race, ethnicity, and (for millions of US patients) types of insurance coverage—enable researchers to pierce the surface of the “patient profile” to reveal the critical differences in access, treatment, and outcome.
We don’t stop at gathering the data. We interrogate it, with best-in-class analytic tools and the brightest minds in epidemiology and evidence generation.
Research Spotlight:
, , , . Race, ethnicity, and utilization of outpatient rehabilitation for treatment of post COVID-19 condition. PM&R. 2022; 14(11): 1315–1324. doi:10.1002/pmrj.12869
Research Spotlight:
Urdang, Zachary D., et al. “Federated Electronic Health Record Database via a Public-Private Partnership to Enhance Health Care Equity by Disparity Discovery and Equitable Clinical Trial Recruitment.” Journal of Health Care for the Poor and Underserved, vol. 33 no. 5, 2022, p. 124-137. Project MUSE, https://doi.org/10.1353/hpu.2022.0162.
Featured Webinar
Diversity in Clinical Trials: Using Real-World Data to Improve Trial Design and Advance Health Equity and Robust Evidence Generation
Featuring guest speakers from Sanofi and Clinical Trials Transformation Initiative, this webinar concluded with a dynamic 15-minute panel discussion moderated by Dr. Jeffery Brown, allowing attendees to engage with the speakers and delve deeper into the presented topics of: real-time access to diverse patient populations, advanced analytics and insights, and secure and compliant data sharing. Don’t miss this opportunity to gain valuable insights from industry experts and contribute to the ongoing dialogue on improving diversity in clinical trials.
Taking Action
As a research leader, you can bring the next chapter of history closer to our ideals—not with a gesture but a commitment to best practices. You can understand the social dimension of disease, scrutinize every protocol’s criteria, and connect with new care institutions and investigators.
But effective action starts with education. Here you will find the latest FDA guidance on diversity in trial enrollment.
