Ideas by Bridgeable

Diversity, equity, and inclusion in clinical research: A way forward

A complex challenge

The COVID pandemic has shed new light on a lingering issue, the lack of diversity, equity, and inclusion (DEI) in clinical trials. The need to address healthcare equity has reached a tipping point. With so many of our outdated systems coming into sharp focus due to the pandemic, we have a real opportunity to make a difference in the way we design and conduct clinical research.

According to the NIH (National Institute of Health), “Coronavirus disease 19 (COVID-19) has disproportionally affected racial and ethnic minority populations, including African American, Hispanic/Latino, and American Indian/Alaska Native individuals, who are three times more likely to be hospitalized than White individuals.” It’s not just about how the COVID 19 clinical trials were conducted- it’s about how most clinical trials are conducted. A recent study of 230 US-based trials with 219, 555 participants confirmed the widespread nature of this problem.

These statistics are shocking but not a surprise. The healthcare community has been wrestling with this complex problem for decades. The FDA has even issued official guidance on this matter, but guidance itself is not going to get us where we need to go. Service design is well positioned to help us solve this complex challenge because of its inclusive approach. Service design methodologies enable clinical trial researchers to uncover the needs of prospective participants living with disease states, whether those needs are health outcome related such as reduced pain or increased mobility, or trust related, and how to build that trust.

We need a paradigm shift in how we think about clinical trial design and recruitment. By addressing this issue head-on, we stand to gain a much-improved healthcare ecosystem, stronger medical research, and increased trust in the industry. Organizations that double down on their DEI efforts and work to re-design clinical trial approaches will feel the trickle-down benefits of solving this critical issue.

Medical ecosystem reform

What is causing this disparity in clinical trial representation? The answer is multi-faceted. At a systems level, factors such as geographic accessibility, insurance barriers, and trial availability play a role in this issue. For example, hospitals operating in under-resourced communities don’t have the research capacity or funding to conduct clinical trials.

From a socio-economic perspective, access to clinical trials is difficult for individuals with limited insurance plans, inflexible full-time employment, and other competing priorities such as childcare. Layer on language barriers and a low health literacy level, and the gap grows wider. “Limited health literacy affects adults in all racial and ethnic groups. The proportion of adults with basic or below basic health literacy ranges from 28 percent of white adults to 65 percent of Hispanic adults.”²

DEI solutions need to encompass all of these perspectives to be effective. They need to consider the lived experience and acknowledge the barriers faced by BIPOC individuals.

Better medical research

Prioritizing DEI in clinical trials is just good science. The more diverse the trial participants are, the stronger our understanding of diseases and conditions. 

“When a more diverse population participates in clinical trials, we increase the potential to know more about the extent to which different subgroups- males and females, young and old, people of various racial and ethnic backgrounds, and patients with differing comorbid diseases and conditions- might respond to a medical problem. The result is greater assurance of the safety and effectiveness of the medical products used by a diverse population.”³

The lack of DEI in clinical trials compromises the quality of findings. This, in turn, limits our knowledge of diseases and conditions and our ability to make sound healthcare decisions. Addressing DEI in clinical research can help reduce risk, inform optimal treatments, and even spark the development of more innovative medications and treatments.

More diverse approaches to clinical trials benefits everyone in the long run, allowing healthcare practitioners to make more informed decisions about medications and recommendations that more closely represent the actual patient populations they work with, and patients to access resources built on the foundation of people with similar lived experience.

Trust and patient outcomes

Relationships are built at the speed of trust. Once trust has been broken, the path to reconciliation and connection is slow. This fact often clashes with deadline-driven clinical trial organizers.

 To reach underserved communities, we must meet them where they are and engage with them authentically. It’s a win-win situation for community members, who may benefit from these new treatment options, and for the organizations running the clinical trials, who need increased enrolment from BIPOC communities. By spending the time and resources to build trust with historically underrepresented individuals, organizations simultaneously improve public perception and confidence in clinical trials. 

This process can take time but can yield wonderful results. We have seen this in our work in community engagement and activation, where we developed a step-by-step guide for designing and facilitating a collaborative workshop intended to convene local community leaders and help communities extend the gains in health equity and access that emerged as a result of community-led responses to the COVID-19 crisis. These conversations were a critical step to sustain and build more equitable and accessible health systems.

A way forward

Everyone deserves safe and effective treatments. There is an opportunity for organizations leading clinical trials to engage meaningfully with BIPOC communities and build the trust required to increase enrolment and retention. 

Here are three things to think about when approaching this work:

1. Community engagement

Building trust with BIPOC communities through effective community engagement is paramount. Meeting people where they are is an important step in repairing broken trust. Simple strategies like hosting community events can go a long way in opening up the conversation and addressing community concerns.

2. Better, more accessible patient information

Most clinical trial literature is inaccessible. It is not designed or written for the population that it targets. If you confuse participants, they are less likely to sign up for trials. A more human approach to information sharing is key. This can mean re-designing patient-facing forms and info packages. It also means equipping providers with strong informational materials they can use when engaging with patients.

Read about Bridgeable’s work in developing the Universal Patient Language

3. Good clinical trial design

Clinical trial design is often copied and pasted, and that’s part of the problem. We have to move past the template approach and forget about saving time. What is of more importance here is designing clinical trials that work and include as many diverse members of the population as possible. Each trial design should expand eligibility criteria and include BIPOC members of the population in appropriate proportion to the general population. Good design is ultimately good for business.

The Bridgeable Way

Activating human-centered design methodologies in solving this challenge can empower the benefits listed above. Learning labs reveal rich insights about the needs and behaviors of patients and healthcare practitioners through custom-tailored activities, uncovering how stakeholders currently experience the clinical trial journey, identifying key pain points, and understanding what elements of the experience are most valuable to redesign.

Co-creation workshops are designed to foster inspiration and generative thought. By inviting every stakeholder to make meaningful contributions that improve the quality of the solution, it enables tangible ideas and humanizes our insights into findings that can be pressure-tested. Co-creations are a creative way to co-design ideas with prospective clinical trial participants, not for them. 

Service design is committed to designing experiences that make life better for patients and healthcare organizations through solutions like learning labs, co-creation, biomedical communications, and more. Bringing an empathic, multi-stakeholder approach to even the most complex challenges ensures that all voices are heard–not just the ones in the room.

Get to know our work and our approach: Reimagining the informed consent experience in clinical trials


1 —”Diversity and Inclusion in Clinical Trials” National Institute on Minority Health and Health Disparities, National Institutes of Health, U.S. Department of Health & Human Services.
2 —”America’s Health Literacy: Why We Need Accessible Health Information” Office of Disease Prevention and Health Promotion, U.S. Department of Health and Human Services.
3 —”Strategies for Ensuring Diversity, Inclusion, and Meaningful Participation in Clinical Trials: Proceedings of a Workshop” National Academies Press, National Library of Medicine.

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