Increasing Diversity in Clinical Trials
As a physician, Dr. Sandra Looby-Gordon probably never thought she’d have to argue with a nurse that her own son needed to be admitted to the hospital. But in September of 2021, she had to do just that.
Her son became sick with COVID-19 and experienced severe shortness of breath. At the time, hospitals were using pulse oximeters to measure oxygen levels to determine admission. His oxygen levels looked normal, and the nurse denied him admission. This decision didn’t sit right with Dr. Looby-Gordon, so she investigated and found that the pulse oximeter may have given an inaccurate reading because her son has a dark complexion. A 2022 study found that pulse oximeter measurements are inaccurate for people with darker skin tones, resulting in patients of color receiving less supplemental oxygen than they need or being denied care outright. Due to her medical knowledge and connections, Dr. Looby-Gordon’s son was eventually admitted to a hospital and fully recovered from COVID-19.
Pulse oximeters are just one example of racial bias in the medical field. Medical products and treatments have historically been based on clinical trials that are made up primarily of white individuals, which can have serious consequences for patients of color. The COVID-19 pandemic helped expose longstanding issues with the lack of diversity in clinical trials and showed that the same disease can impact vulnerable populations very differently. Below we dig deeper into this issue and provide some solutions that will ensure people of different races, ethnicities, sexes, ages, lived experiences, and backgrounds all benefit equally from scientific advances.
People of Color are Underrepresented in Clinical Trials
Ninety-six percent of modern studies on disease genetics have been conducted on white people, despite composing just 60% of the population. And when you look at incidence rate of chronic illnesses versus representation in clinical trials, the gap gets even worse. People of color are more likely to have chronic illnesses like heart disease, hypertension, diabetes, and cancer, so it would make sense to include them in trials at higher rates since they would optimally be receiving the most treatment for these ailments. But people of color often face barriers to clinical trial participation. People of color are less likely to have the resources to take time off work, pay for childcare, and arrange transportation—especially if the trial location is miles away. They face racism and bias when seeking out health care broadly, making them less likely to trust medical professionals. And historical atrocities like the Tuskegee syphilis study have driven deep mistrust in clinical trails among communities of color.
Further, ethnic and racial groups often have genetic differences, meaning people may react differently to therapies and medications. We saw this with pulse oximeters because they hadn’t been properly tested on people with higher levels of melanin. If diverse groups aren’t a part of these studies, we can’t be sure if and how effective the treatment would be in all patient populations or what side effects might emerge.
How to Reduce Barriers to Clinical Trial Access
To increase diversity in clinical trials, we need to tackle many barriers keeping people of color from participating.
First, improving enrollment and retention practices would enhance inclusiveness in trials. Companies should ensure the research materials they provide use accessible language and address common concerns, such as possible side effects and the necessary time commitment. They can make participation less burdensome by utilizing telehealth services and digital technologies, local labs in communities, sending medicine directly to participants, covering transportation and wraparound services, or providing incentives to participants. And most importantly, they should intentionally recruit people from underrepresented groups. The NIH Clinical Trial Diversity Act introduced by Representative Robin Kelly would require NIH-funded trials to follow clear recruitment and retention goals and ensure the availability of less burdensome follow-ups. The bipartisan Diverse and Equitable Participation in Clinical Trials (DEPICT) Act introduced by Representative Anna Eshoo would require applicants to report clinical trial enrollment targets by demographic subgroup and provide a Diversity Action Plan to meet these targets.
Second, broadening eligibility criteria for trials would also improve diversity. The Food and Drug Administration (FDA) issued a guidance in November 2020 with respect to broadening eligibility criteria to ensure enrollment of a diverse population that clinical trial sponsors should consider. Companies should also consider reducing criteria, when medically feasible, that exclude certain medically complex patients, who are disproportionately people of color, that have been historically excluded from trials.
Third, companies should also establish research locations in Black and Brown communities to make trials more accessible. Participating in clinical trials can be a whole day affair. Participants usually have to travel to a central location, like a university hospital, which can be a several hour drive for some. It might require taking the day off work and finding childcare, making it inaccessible to many low-income people. Companies should establish research sites in communities of color and utilize locations where participants already receive care, including non-traditional locations like community health centers and pharmacies, and integrate digital health technologies to allow for remote participation. This would make trials more accessible and likely increase enrollment as local health professionals and practices have spent years building trust with community members. Two bipartisan bills in Congress would help set up these decentralized locations. The DEPICT Act would provide funding to community health centers to increase capacity to participate in clinical trials. And the Diversifying Investigations via Equitable Research Studies for Everyone (DIVERSE) Trials Act, introduced by Representative Raul Ruiz and Senator Bob Menendez, would require the Department of Health and Human Services (HHS) to issue guidance on how to conduct decentralized trials.
Fourth, studies have shown that people of color feel more comfortable and receive better care when their doctor looks like them. Hiring more principal investigators of color would help increase trust with participants of color. A more diverse workforce would ensure participants receive culturally competent care and make it easier for non-English speaking people to participate. Members of Congress have introduced legislation setting guidelines for participant diversity in clinical trials. They could do the same for staff diversity.
Finally, community outreach is vital in building trust with a community. Companies should create outreach programs to partner with local community centers and organizations to educate members of the community and enroll them in trials. They should also work with patient advocacy organizations to incorporate patient input into their trial design. Working with trusted community messengers and groups and continuing investment in these communities will help increase participant diversity. The DEPICT Act and DIVERSE Trials Act would both provide grants to support these education, outreach, and recruitment efforts.
People of color are woefully underrepresented in clinical trials, often for treatments for chronic illnesses that disproportionately affect them. There are many barriers keeping them from participating in clinical trials, from financial restraints to lack of transportation and childcare. Many solutions have been identified by companies working in health care and introduced as legislation by Congress. Now it’s time to implement them to reduce barriers to access and build trust in underrepresented communities.