Diversity and inclusion in clinical trial cohorts aren’t merely nice to have. They are essential to ensure equitable representation and to generate trial results that can be generalized to a larger population.
By leveraging deep pools of publicly-available data, clinical trial teams can identify underrepresented populations, analyze sociodemographic factors, and inform diversity strategies for better diversity and inclusion in clinical trials.
Diversity and Inclusion in Clinical Trials: Where Are We Now?
“Historically, clinical trials did not always recruit participants who represented the individuals most affected by a particular disease, condition, or behavior,” notes the National Institute on Minority Health and Health Disparities. Consequently, many clinical trial results contain “gaps in our understanding” of disease, treatment, and prevention.
Efforts to boost diversity and inclusion in clinical trials seek to fill these gaps. The COVID-19 pandemic accelerated impetus to build diverse, inclusive patient cohorts, as the disease disproportionately affected racial and ethnic minority groups in the United States and elsewhere.
In one study, authors Jameka Hill, Diane Montross, and Melanie Ivarsson outlined efforts to build more diverse and inclusive patient cohorts during COVID-19 mRNA vaccine trials. Hill et al. identified five factors that helped improve enrollment diversity throughout a phase lll trial of an mRNA vaccine:
- Oversight: Establishing a Diversity and Inclusion Advisory Committee to address diversity and inclusion issues and listening to the committee’s recommendations.
- Engagement: Working with key stakeholders to establish the need for diverse representation and methods for achieving it.
- Communicating: Using inclusive materials to communicate with trial participants.
- Connecting: Identifying and pursuing avenues to reach more diverse, inclusive groups of potential trial participants.
- Disclosing: Improving transparency with trial participants to build trust.
“This work shows that diversity and inclusion in clinical trials can be attained even in the most extreme circumstances and highlights the importance of efforts toward building trust and empowering racial and ethnic minorities with the knowledge to make informed medical treatment decisions,” write Hill et al.
Clinical trials play a key role in identifying new treatments, therapies, and interventions. They also offer new avenues for diagnosis and improving quality of life. With more diverse and inclusive patient cohorts, treatments, therapies, interventions, and diagnostic tools can more effectively serve broader populations.
How Data Shapes Diversity and Inclusion in Clinical Trials
In pursuit of ways to boost diversity and inclusion in clinical trials, some research teams have turned to available data sets to identify gaps and find or build more diverse, inclusive patient cohorts.
Early efforts to use data sets to this end, however, faced challenges. For instance, “data sources shown to lack representativeness of the US population with respect to diversity include commercial health insurance claims, databases from academic tertiary care centers, and geographically limited healthcare networks,” write Elizabeth S. Russell and fellow authors in a 2023 article in the Journal of Clinical and Translational Science.
Meanwhile, data sources that contain diversity data may not represent the general population or may lack the privacy controls necessary for effective use of the data in healthcare.
Using data to improve diversity and inclusion in clinical trials, then, demands a balance among several factors: completeness, accuracy, privacy, and representativeness.
Russell et al. note the challenges in finding a single data source that meets all these needs. So does the FDA’s recent guidance on diversity and inclusivity in clinical trials, which does not spell out details as to how clinical trial teams should implement a data-driven approach. The FDA encourages sponsors to leverage various data sources (e.g., epidemiology, published literature and demographics in the overall population). Digital solutions that pull from many existing data sources to build a comprehensive picture may prove to meet these needs.
Data-Driven Solutions for Fostering Diversity and Inclusion in Clinical Trials
Diversity and inclusion efforts work best when incorporated early in the clinical trial design, budgeting, and site selection process, write Lori Carter-Edwards and fellow authors. Doing so can “support the development of a clinical research system that is intentionally inclusive, and therefore more closely aligned with the needs of patients,” write Carter-Edwards et al.
Solutions like Anju’s TA Scan provide the data-driven insights, tools, and support required to incorporate diversity and inclusion efforts into the earliest stages of clinical trial planning. TA Scan provides unparalleled global public data access in an intuitive, web-based clinical business intelligence platform.
Within TA Scan, diversity and inclusion teams can:
- Access deep pools of publicly-available data for more insightful decision-making. TA Scan contains fully integrated demographic and diversity data including population and patient data from countries across the globe.
- Save time and manual effort via TA Scan’s data and built-in analytics and quickly browse through relevant publications to develop a clearer picture of the subpopulation to set enrollment goals.
- Obtain experience-based insights from clinical trial sites and principal investigators and visualize site and PI experience together with diversity and socio-economic data on a single map.
- Improve site selection timing and choices by understanding where competing trials are taking place and selecting a time and place for a clinical trial that maximizes opportunities to reach a diverse, inclusive group of potential participants.
A diverse, inclusive participant cohort provides a clearer understanding of how treatments and therapies work. It offers stronger data sets that are more easily generalized. It is, in a word, essential. Data-driven solutions like TA Scan can help clinical trial teams build more diverse and inclusive clinical trial patent cohorts.
Images used under license by Shutterstock.com.
Authored by Elke Ydens, Associate Director of Business Solutions, Data Division
Elke Ydens, Associate Director of Business Solutions at Anju’s Data Division, brings over a decade of life sciences experience and a PhD in Biochemistry and Biotechnology from the University of Antwerp. As a Subject Matter Expert in Data Science, she adeptly addresses customer needs, leveraging her background in neuro-immunology and biochemistry. Elke remains dedicated to professional growth, contributing to industry publications, and staying updated on industry trends, while also finding success in extracurricular pursuits, formerly competing in world and European bridge championships, and more recently active in beekeeping and coaching. Connect with Elke on LinkedIn to explore her achievements further.