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Increasing Diverse Clinical Populations: Race & Ethnicity

Cassidi Williams

Lacking Representation in Medical Research

The lack of representation and diversity in medical research is partially driven by a lack of access to clinical trials. Studies with limited diversity can create significant limitations on the conclusions drawn from study data. Attracting a diverse population of patients for a clinical trial is critical for patient health and long-term community wellness. After all, medications may impact demographics uniquely by age, race, gender, and other factors. Trials need to draw on similarly diverse groups of patients to ensure safety and efficacy. This is now recognized by regulatory agencies. In 230 trials for FDA approval of oncology drugs over the past decade, only 145 trials (63%) reported race. Black and Hispanic people were underrepresented in these trials relative to their proportion among the U.S. cancer population.(1) This three part blog series will examine the varied challenges and potential solutions to increasing diversity in clinical research. In Part 2, we’ll look at how research can better address race and ethnicity to better serve patient populations and overall community health.

In 230 trials with a total of 112,293 participants, only 18 trials (7.8%) documented the four major races in the U.S. (white, Asian, black, and Hispanic). Only 58 trials (25.2%) reported race subgroup analyses. Reporting on white, Asian, black, and Hispanic races was included in 144 (62.6%), 110 (47.8%), 88 (38.2%), and 23 (10.0%) trials, respectively.(2) Another FDA study reviewed dermatological drug trials conducted between 1995-2019 and found White participants were predominantly overrepresented while Black and Asian participants were consistently underrepresented.(3) These disparities become even more prominent when we examine how health conditions affect certain races or ethnic groups. One such is the field of cardiovascular disease, which disproportionately affects Black patients in the United States. According to the 2018 national vital statistics report, African Americans were 30% more likely to die from heart disease than non-Hispanic whites. However, the FDA found that African Americans only accounted for 2.5% of cardiology clinical trial participants.(4) Differences in drug response by race can be critical - for example studies show that the recommended maintenance dose for warfarin of 5 mg is in fact too much for many Asian patients and too little for many Black participants.(5) Identifying differences such as this can be particularly challenging when studies under-recruit racial and ethnic minorities.

How to Increase Diversity & Representation

There is no easy solution to successfully recruiting more representative populations. Many structural challenges in recruitment are embedded in medical systems which often are extensions of power dynamics that may disproportionately disadvantage some populations compared to others. Across multiple measures of healthcare, people of color fare worse than their white counterparts in America.(6) These existing disparities are then reflected in clinical trial recruitment and engagement.While no panacea for social inequality, when used effectively technology may mitigate some of the underlying challenges to inclusion in clinical research. Decentralized clinical trials (DCTs) and the digital approaches they employ can help bring research opportunities to a broader range of candidates. Over time, research funding has been focused on large clinical centers, resulting in an entrenched clinical trial infrastructure. DCTs allow us to expand beyond that infrastructure. For example, promotion and recruitment for clinical research has historically happened in places (real and online) where audiences are neither racially nor ethnically diverse. DCTs can expand that outreach, empowering more physicians and patients to learn about studies.

Retention of diverse and qualified patients has also plagued the industry. Building trials with inclusion in mind, and incorporating approaches to engage racially and ethnically diverse populations, should be a part of all design and operational decisions. In one study, researchers from Duke utilized video during the informed consent process at some sites, and traditional consenting at other sites. When video was used during the consenting process there was a statistically significant increase in patients average age, non-white participants, rural participants, and a nearly 40 day decrease in first-patient-enrollment.(7) One minor change toward tech-enablement was sufficient to drive improvement. Deploying hybrid and decentralized trials that move towards more tech-enablement can further decrease barriers to entry by building trust, offering flexibility, helping clear economic obstacles to participation, tracking outreach, measuring results, and sharing learnings.

Gaining Trust with Marginalized Communities

Before jumping to a quick tech-bandaid, it is critical to consider that historically marginalized communities have often been subjected to tech implementation that claims to meet their needs but does not consider their underlying challenges. One key to increasing retention metrics is to directly engage the population and solicit feedback prior to finalizing a protocol. In many communities there is a trust gap between care providers and those that receive care. Identifying community specific concerns and directly addressing those is indispensable from an ethical and effective program intended to increase inclusion.

For ethical, scientific, and regulatory reasons, racial and ethnic diversity are increasingly important to clinical development. A decentralized approach can be part of a program to increase inclusion by decreasing physical and economic barriers to research participation. Meeting research diversity goals will require contributions from across the life sciences industry. Sponsors and CRO’s can help lead the way through the use of DCT models and proactive reach out to historically marginalized populations. Read our report How DCTs Make Research More Accessible and Inclusive for Participants and Sites to learn:

  • How DCT elements can help address the barriers to effective enrollment
  • Key ways DCT approaches can reduce the need to exclude patients based on geography
  • Strategies for improving access to research for both participants and sites

(1)Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018

(2)Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018

(3) Science Direct

(4)Clinical Trials Arena

(5)Ethnic Differences in Cardiovascular Drug Response: Potential Contribution of Pharmacogenetics

(6)Key Facts on Health and Health Care by Race and Ethnicity

(7) An Observational Study of the Association of Video- Versus Text-Based Informed Consent With Multicenter Trial Enrollment: Lessons From the PALM Study (Patient and Provider Assessment of Lipid Management)

Farwa Abbas
Manager, Strategy

Farwa has extensive experience in early drug discovery and has contributed significantly to the strategic advancement of therapeutic portfolios. She brings 10+ years of experience in biopharma to THREAD where she continues fulfilling her passion to accelerate drug development by bringing technology-enabled solutions to the life science industry.