How to advance diversity, equity and inclusion in clinical trial recruitment

The principles of diversity, equity and inclusion (DEI) are now a commonplace expectation in our world, positively impacting everything, from workplaces to classrooms to hospital halls. This ethos encourages all of us to be more thoughtful, equitable, and humane when considering how our choices impact racial diversity, socio-economic and geographical disparities, environmental impacts, and more.

DEI also has a significant role to play in clinical trials.

Despite comprising 39% of the American national population, racial and ethnic minority groups are severely underrepresented in US clinical trials. Furthermore, this population disproportionately suffers from chronic diseases, yet, they make up as little as 2% of the patients involved in biomedical research studies. Consider this. In a recent article on the topic of ‘Inclusion and Diversity in Clinical Trials’, the authors noted that, of the 32,000 individuals who participated in new drug trials in 2020, 8% were Black, 6% were Asian, and 11% were Hispanic. These disparities can make it difficult to accurately determine the safety and efficacy of a drug across populations, which puts certain people at greater risk of health complications and the ensuing healthcare costs.

After all, genetics – which vary across racial and ethnic groups – influence physiological responses to drugs. For instance, Asians, Latinos, and African Americans who take the blood clot mediation warfarin, and suffer from atrial fibrillation (irregular heartbeats), are at higher risk of brain bleeding compared to individuals of European ancestry.

For clinical research to be truly reflective of our populations, DEI-oriented strategies need to take higher priority in clinical trial recruitment. It is important that the BioPharma industry, as well as physicians, recognise and address the numerous barriers to clinical trials that minorities frequently encounter.

Barriers & solutions

Though demand for clinical trial participants is rising, recruitment is hindered by ongoing factors that perpetuate biased results and potentially expose minority populations to ineffective or unsafe drug treatments. Fortunately, DEI strategies can improve the clinical trial experience for underrepresented groups.

Study Design

One issue is the conventional design of clinical studies, namely eligibility criteria. While these guidelines standardise participant characteristics to ensure accurate results based on one shared factor, they can unintentionally exclude marginalised populations, due to health disparities. For example, people of African ancestry are often designated ineligible for cancer trials due to naturally lower neutrophil counts (a type of white blood cell) than White patients.

Adjusting eligibility criteria through the lens of DEI, however, can turn such barriers into new research opportunities. Instead of excluding individuals who don’t meet necessary biological criteria, biopharma companies could take this as an opportunity to design specialised trials that examine unique biomarker variations and implement targeted therapies, encouraging more diverse enrolment.

Geographical and socioeconomic pressure

The bulk of clinical trial and recruitment sites are clustered in urban areas or large academic centers, complicating access to assessments and follow-ups for minority groups or people who live in rural areas. Sites that are located rurally are sparse by comparison.

But clinical trial sites could be shifted to areas that are centrally located to underrepresented populations. Popular locations within target communities can even be selected as grounds to expand and diversify patient recruitment, such as community centres, faith-focused centres, and local physician offices. Partnering with organisations that enable diverse community outreach, such as the National Minority Health Association, could further increase patient diversity in future clinical trials.

Beyond inconvenient locations, the costs of treatment, transportation, lost work, and more are often enough to discourage some individuals from enrolling in clinical trials altogether.

One possible route to reduce these socioeconomic barriers is by decentralising clinical trials – that is, providing participants with wearable technologies, giving disadvantaged patients the ability to take part in clinical trials virtually from their own homes. Decentralising clinical trials in this way can also incorporate hybrid participation models, either through electronic check-ins, at-home visitation, or mobile nursing units.

Health literacy

Those who overcome the above barriers must still navigate clinical trial databases like clinicaltrials.gov, a challenging task for individuals unfamiliar with healthcare nuances and procedural jargon. In many cases, this information barrier deters broader participation and reduces diversity among clinical trial participants. In fact, a survey across eight European countries revealed that at least 1 in 10 respondents exhibited insufficient health literacy, with higher rates observed among those with lower income and education levels.

To improve awareness, biopharma companies could leverage social media, digital marketing, and location-based ads to more effectively reach specific audiences. Clinical trial sponsors could also collaborate with local physicians to distribute materials to patients with information about clinical study enrolment. Patient navigators can provide additional support for individuals when navigating whether a clinical trial is relevant and suitable for them.

Language barriers

Minority groups are more likely to face language barriers. One study, for example, found patients with limited English proficiency were 3.4 times less likely to participate in gynaecologic oncology trials than fluent English speakers. As an example of the complications that language barriers can cause, patients may also fail to report adverse events accurately or in a timely enough manner, which not only compromises trial results, but also discourages future participation.

Diversifying the clinical research workforce may flip the script. Researchers are more effective at recruiting participants with whom they share a cultural or linguistic background. Incorporating bilingual staff or interpreters into clinical teams will help non-native English speakers feel more at ease while participating in clinical trials. In addition, participants could be given access to multimedia educational materials written in their native language. AI could also be integrated into online clinical portals to translate difficult medical concepts into laymen’s terms.

Stand by DEI

Infusing DEI considerations into clinical trial recruitment and enrolment will prove crucial for drug discovery and novel therapies. But it will do so much more, too.

Biopharma companies and physicians who embrace DEI won’t just provide racial and ethnic groups with the access to the clinical trials suitable for them: they will have the opportunity to emerge as stronger players in the public health industry, breaking down longstanding recruitment barriers, enriching research procedures, and improving health outcomes for all.