How to Enhance DEI in Clinical Trials

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Diversity, Equity and Inclusion (DEI) is an organizational framework that strives to give equal opportunities to all people regardless of their race, ethnicity, gender identity, sexual orientation, physical ability or religion. DEI rests on a series of values that encourages companies to be consciously inclusive with their employees, customers, collaborators, and any other person who may come into contact with the organization.

Among the many industries poised for improvement via DEI strategies is healthcare, where the stakes of equitable and ethical care can have profound consequences on patient outcomes. This need is especially true in the case of clinical trials, where the failure to reflect diverse populations has adverse repercussions for public health.

Inequality in clinical trials

Clinical trials that only research a narrow demographic group are less likely to accurately represent the broader population and can lead to drugs being ineffective and even harmful to certain groups within the broader population.

Naturally, the clinical trial landscape does not exist in a vacuum and is affected by ingrained social biases. To give one example, according to the 2020 census, 30-40% of the US population is made up of minorities. However, an analysis1 of 32,000 individuals who participated in new drug trials in that same year found that only 11% were Hispanic, 8% were Black, and 6% were Asian. Findings even suggested that underrepresentation in clinical trials has worsened in the past 5 years.¹

Meanwhile, principal investigators (the people running a clinical trial) who identify as White are nearly twice as likely² to receive funding for independent grant applications as principal investigators who identify as Black. These biases may have a direct impact on research priorities.

Patients are also more likely to participate in clinical trials when they share a background with the researchers. In ophthalmological clinical studies³, only 39% of patients participated in clinical trials run by research staff of a different race or ethnicity to their own, as compared to 65% who consented to work with providers of their same race or ethnicity.

Another manifestation of inequality in research is that $2,800 per capita is allocated for cystic fibrosis research, most prevalent among White communities, as compared to the $812 per capita allocated for sickle cell disease research, where more than 90% of US patients⁴ are non-Hispanic Black or African American. This disparity demonstrates how deeply ingrained racial inequality often is throughout the medical research community.

DEI as part of the solution

These examples illustrate how wider societal disparities can affect the clinical trial landscape, and why it is essential⁵ to ensure that clinical trials yield results that are applicable to diverse populations. Fortunately, the industry’s awareness of the situation has increased in recent years, and there are already practical instances to illustrate how prioritizing DEI in clinical trials can better determine the efficacy of drugs under development for all people who may need them.

For example, ACE inhibitors, medications used to treat hypertension (high blood pressure), have proven less effective⁶ in Black patients as compared with White patients. This is likely due to variations in the hormone system that regulates blood pressure (the renin-angiotensin system), affecting the way these drugs work. Through more representative clinical trials, scientists found that alternative medications like calcium channel blockers are more effective among many Black patients.

With more equitable results for everyone in mind, clinical trial organizers can use a variety of methods to deploy DEI strategies and improve clinical trial outcomes.

Steps towards implementing DEI in clinical trials

Firstly, clinical trial design strategies that prioritize DEI can increase participation by underrepresented groups by reducing socioeconomic barriers and geographic obstacles. Covering travel expenses or introducing decentralized trial solutions like wearable digital trackers, home visits, and mobile research units can help reduce the burden of transportation and increase participation of populations in rural areas and those for whom travel poses a logistical or financial burden. Clinical trial sites could also be set up in areas that are centrally located for underrepresented groups, or they could take place at community hot-spots such as faith-based organizations and community centers.

Steps can also be taken to address a lack of trust, as well as language and information barriers. It is unsurprising that, as a result of the known disparities between different groups, there has often been mistrust and skepticism towards the healthcare establishment within underrepresented communities. A recent study⁷ found that, compared with individuals identifying as White, members of Black and Latino communities were 73% and 49% more likely to report mistrust in health professionals, respectively. Historical abuses, like the Tuskegee Syphilis experiment (where 399 Black men with syphilis, out of a 600-person research pool, were denied critical penicillin treatment so as not to disrupt the study), may have increased this sense of fear and mistrust⁸ in underrepresented people who are approached to participate in clinical trials.

Engaging with these communities throughout the clinical trial process helps foster trust and increases willingness to participate. The benefits become even more pronounced when clinical trials actively involve these potential participants in study design and recruitment strategies and share the results with them.

Non-native English speakers, such as immigrant populations, also often experience difficulties in navigating clinical trials. Offering patients clear educational materials in their native language throughout the clinical process will help them better understand the risks and benefits of joining and participating in a study. For further support, Patient Navigator services with staff fluent in multiple languages can be used to guide patients through every step of the clinical trial discovery process in their native tongue. By including bilingual staff on teams or offering translation and interpretive services, non-native English speakers may receive a better understanding of clinical trials and may be more likely to participate and continue within the study.

To further empower patients with information, there are also clinical trial search platforms powered by AI that can enable patients to search for relevant trials and receive practical and easy to understand information that can be discussed with their physician.

A diverse world is a healthier world

Integrating DEI strategies into clinical trials is both crucial for advancing biomedical knowledge and for bolstering trust and equitability within underrepresented communities. Together, we can build a smarter, healthier, and more just world.

Michel van Harten MD, CEO of myTomorrows

References

1. https://www.sciencedirect.com/science/article/abs/pii/S1551714422000660?via%3Dihub
2. https://diversity.nih.gov/sites/default/files/media-files/documents/September%202022%20SWDSS%20Proceedings.pdf
3. https://healthcity.bmc.org/diversifying-research-staff-linked-critical-increase-racially-diverse-clinical-trial/
4. https://www.cdc.gov/sickle-cell/data/index.html
5. https://www.nejm.org/doi/full/10.1056/NEJMp2215609
6. https://pubmed.ncbi.nlm.nih.gov/29808707/
7. https://pmc.ncbi.nlm.nih.gov/articles/PMC7800756/
8. https://news.stanford.edu/stories/2017/01/stanford-researchers-explore-legacy-tuskegee-syphilis-study-today