Clinical trial disparities and how to build a more inclusive future
Historically, clinical trials have lacked diversity amongst both study participants and researchers. This has resulted in a lack of ability to evaluate fully and effectively the safety and efficacy of new drugs and therapies across the general population.
This problem is not without a solution. With an intentional focus on diversity, equity, and inclusion and the use of innovative technologies, clinical leaders can build a more inclusive future for clinical trials and their participants.
A disparity in representation
One of the most significant challenges is the underrepresentation of racial and ethnic minorities, older adults, and women in clinical research. Over the past twenty years, the majority of US trials in ClinicalTrials.gov do not report race/ethnicity enrolment data, and in those that do, minorities are underrepresented in trials with modest improvement over time.1
While racial and ethnic minorities comprise 41.1% of the US population,2 median trial inclusion for these groups only lies at 27.6%.3 Hispanics, for example, comprise roughly 17.8% of the US population, yet only account for less than 3% of cancer clinical trial participants.4
This disparity poses a serious risk to clinical trials, as it fails to account for variability across different ages, races, underlying conditions, socioeconomic backgrounds, digital literacy experiences, genetic factors, and genders.
The lack of diversity doesn’t just stop at patient groups: clinical providers are homogeneous as well. The National Institute of Health reports that only 3.3% of all doctorates awarded in the biological sciences were earned by African Americans.
Furthermore, studies show a disproportionate amount of research funding is awarded to underrepresented minorities. Controlling for education, country of origin, previous research experience and awards, evidence of publications, and employer attributes, African American applicants were 10 percentage points less likely than Caucasians to receive research funding.5 The shortage of diversity and disparity of funding among clinical researchers and leaders shapes the types of therapies studied, the way trials are designed, and how trials are conducted.
The lack of diversity in clinical providers and staff also contributes to the lack of diversity in trial participants. For example, language barriers can hinder enrolment of diverse patients if clinical providers cannot fluently communicate in a participant’s native language. Implicit biases among providers could also subconsciously affect how they assess eligibility and interact with minority patients.
Additionally, minority patients tend to prefer providers who share their racial and ethnic backgrounds because they feel their needs are better understood. In a study from the University of Pennsylvania, researchers found that patients who worked with a provider of the same race/ethnicity led to higher chances of receiving maximum patient experience scores.6
Charting a more inclusive future
Improving diversity starts with proactive and thoughtful outreach to minority communities. Leaders must invest time in building trust, fostering foundational relationships, and laying the groundwork for engaging with minority communities.
Clinical leaders should proactively connect with civic organisations rooted in minority communities, like local chapters of racial and ethnic minority professional groups, advocacy groups, and cultural associations. These groups understand the minority population and can help spread awareness of the need for diverse patients and researchers. Moreover, partnerships with regional clinics, hospitals, and providers focused on serving minorities can provide a direct channel for patient and researcher recruitment.
It is also crucial for researchers and clinicians to speak the language of underrepresented populations in a way that they understand. This not only means recruiting culturally competent leaders who are conversant in participants’ native languages, but also ensuring that all patient-facing documents and study materials are written in a way that is easily comprehended. By writing important documents, such as consent forms, at the average literacy level and in multiple languages, clinical leaders can improve accessibility for patients of various backgrounds.
Finally, emerging technologies like telemedicine, wearables, and mobile apps enable decentralised trials to be conducted digitally across different communities. These innovations help to lower the barrier to entry, expand access to trials, and promote patient convenience. Decentralised methods also allow for an expanded pool of participants by eliminating challenges such as taking time off work to travel to and from a clinic. These changes can lead to higher enrolment amongst working parents, rural residents, and other patients facing geographic and time constraints.
Achieving true equity in clinical research requires a commitment across the entire scientific community. For example, sharing de-identified data from electronic healthcare records across facilities and healthcare networks could make it easier to identify diverse candidates who could be a good match for a trial.
Clinical leaders should aim to make trials fully representative of real patients. This will only be possible through focused effort, commitment, thoughtful consideration of underserved groups, and the adoption of improved processes and enhanced technologies.
- National Institute of Health, Race/ethnicity reporting and representation in US clinical trials: A cohort study, Turner et al. (2022), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9302767/
- United States Census, https://www.census.gov/quickfacts/fact/table/US/PST045217
- The Lancet, Race/ethnicity reporting and representation in US clinical trials: A cohort study, Turner et al. (2022), https://www.thelancet.com/journals/lanam/article/PIIS2667-193X(22)00069-2/fulltext
- ScienceDirect, Operational strategies in US cancer centers of excellence that support the successful accrual of racial and ethnic minorities in clinical trials, Regnante et al. (2020), https://www.sciencedirect.com/science/article/pii/S2451865420300168
- National Institute of Health, Building the Network of Minority Health Research Investigators: A Novel Program to Enhance Leadership and Success of Underrepresented Minorities in Biomedical Research, Blanchard et al. (2019), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6428177/
- JAMA Network, Association of Racial/Ethnic and Gender Concordance Between Patients and Physicians With Patient Experience Ratings, Takeshita et al. (2020), https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2772682?utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_term=110920