Diversity in Clinical Trials: The Need to Recruit More Ethnically Diverse Patient Populations

This blog was authored by Fiona Maini, Global Compliance and Strategy Principal at Medidata.

The COVID-19 pandemic represented a turning point for healthcare. This situation prompted a rapid shift of resources and services to help maintain and control the virus, as well as a necessity for innovation accelerating the pace of change in the field. The events of 2020 also brought the issues of racial discrimination and associated inequities to the fore, with organizations across sectors doubling down their efforts to promote diversity in clinical trials and champion the voice of underrepresented groups.

Despite this, of the 53 novel therapeutics approved by the FDA in 2020, over 75% of the 32,000 patients participating in these clinical trials were white¹. Longer-term analyses show similar statistics, with only 5% of people taking part in research being of Black or African American origin².

What are the past and present barriers to trial participation for patients from underrepresented groups?

There are many historical reasons why minority groups have received disparate treatment in clinical trials. 

Now, even with overt racism having been largely eradicated from medicine, patients from racial and ethnic minorities still face substantial barriers to participation in research. These include:

• Income disparities – which prevent people from enrolling in trials where there are out-of-pocket expenses not covered by the research team
• Physical limitations – trials are not often conducted in locations with diverse patient populations and participants may be unable or unwilling to travel long distances to reach clinic sites
• Linguistic and cultural barriers – language barriers make it difficult for trial participants to understand the research process and relevance of the trial
• Lack of awareness and trust – the engagement of researchers and sponsors with minority groups is too often inadequate. There also remains a lack of trust between these communities and the research field—likely due to the long history of scientific exclusion

Why is promoting racial diversity in clinical trials so important?

Diversity in clinical trials is critical to ensure that a drug is efficacious for all the patients to whom it is administered. Many variables affect how a person responds to treatment, including race or ethnic background. This may be due to intrinsic factors, such as genetics and ancestry, or extrinsic factors, including diet, environment, and sociocultural issues. Collecting data on a wide variety of patients and performing in-depth analyses can identify population-specific signals related to drug metabolism, safety, or efficacy and provide an insight into the optimal therapeutic approach for different ethnic groups.

Unfortunately to this day, many studies do not recruit diverse patient populations; of those that do, few perform the necessary analyses to clarify links between a person’s race and their treatment response. 

Ethical and legal safeguards have been put in place to increase clinical trial diversity and allow for robust data generation to better inform patient care. Rulings on diversity in clinical trials have been introduced, such as the National Institutes of Health (NIH) Revitalization Act of 1993, which mandated that members of minority groups be included in all NIH-funded clinical research³. And, in 2010, the FDA Office of Minority Health and Health Equity was established to reduce health disparities among racial and ethnic subgroups⁴.

Community-based participatory programs have also been effective in increasing participation in, and decreasing mistrust of, medical research among minority communities. These programs create a ‘collaborative approach to research that equitably involves all partners in the research process’⁵. 

What more can be done to increase diversity in clinical research?

Given that racial and ethnic minorities are still underrepresented in trials, more consideration is needed to determine solutions to address these health inequities. Although there has been significant progress in the efforts made to recruit patients who reflect the diversity of the general population, much more needs to be done.

At Medidata, digital innovations are paving the way to a new era of more inclusive, accessible trials. The use of virtual tools and technology across the clinical trial process can help increase diversity. Some of these tools include:

• Acorn AI’s use of data analytics to identify suitable patients and site locations
• Use of electronic informed consent and trial decentralization tools to increase the accessibility of trials and reduce burden on participants
• Better patient education and engagement through telemedicine
• Risk-based monitoring to build in measures around diversity metrics
• Clinical Trial Management System (CTMS) incentivizing patients through prompt payment

Additionally, Medidata’s Diversity in Clinical Trials Steering Committee was set up in 2017 to raise awareness for the underrepresentation of minorities in clinical trials. The committee’s focus areas include patient-facing initiatives and thought leadership, as well as leveraging Medidata’s product-and-service solutions to bridge the diversity gap⁶. Since its inception, the group has created a proof-of-concept visualization tool to help study teams monitor progress on trial diversity by comparing clinical trial participant data against real-world benchmarks. The team has also conducted educational sessions to raise awareness about diversity challenges at conferences such as the Summit of Clinical Operations Executives, Society for Clinical Research Sites, and Medidata’s Global NEXT.

Solving the issue of racial inequality in clinical research will require stakeholders from across the life sciences and pharmaceutical industries to work together and create innovative solutions which promote diversity. These must focus on increasing accessibility and fostering a culture of inclusion, which is crucial for trial participants, physicians, and research teams. Healthcare leaders of the future must not only embrace diversity, but also represent it, if we hope to make truly meaningful change.

References

¹ FDA 2020 Drug Trials Snapshots Summary Report

² Clinical Research Pathways - Diversity in Clinical Trials

³ National Institutes of Health Revitalization Act of 1993

⁴ FDA Office of Minority Health and Health Equity

⁵ A Systematic Review of Community-Based Participatory Research to Enhance Clinical Trials in Racial and Ethnic Minority Groups

⁶ Medidata – Diversity in Clinical Trials