Clinical Researcher—October 2022 (Volume 36, Issue 5)

PEER REVIEWED

Kate Schroeder; Seth Palmer, MBA, CDMP

It is crucial to improve diversity, equity, and inclusion (DEI) in clinical trials for the health and well-being of everyone. Health disparities and inequities among marginalized communities reflect the institutional structures that impede communities from accessing healthcare and clinical studies. There are many steps the industry can take as it strives to improve upon DEI, including increasing diversity among leadership and physicians, destigmatizing clinical research, translating recruitment and retention materials to multiple languages, focusing on DEI when building out protocols, and more.

The points outlined in this article offer some guidance for the clinical research industry but are not comprehensive. Rather, the suggestions highlight the importance of DEI in clinical research and further the discussion toward meaningful change. Moreover, any claims made about the experiences of people of color, LGBTQIA groups, socioeconomically disadvantaged populations, or people with disabilities are not representative of entire communities. Additionally, this article does not address intersectionality due to the lack of data around patient populations belonging to multiple groups.

Background

Clinical research is the backbone of healthcare advancements, but historically, clinical trials have lacked diverse representation. The process of patient recruitment and retention, the demographic makeup of the healthcare industry, and the biopharmaceutical industry as a whole need impactful change.

Age, family medical history, environmental conditions, physical and mental well-being, and many more factors can potentially impact the effects of certain medications and treatments. Moreover, clinical trials are often the first chance to receive a new, potentially life-changing or life-saving treatment. Therefore, patient recruitment and retention campaigns and clinical trial processes must be appropriately inclusive of everyone.{1} With many elements of diversity, the clinical research industry must improve inclusivity across all identities, including for racially or ethnically marginalized groups, LGBTQIA communities, socioeconomically disadvantaged populations, persons with disabilities, people of all ages, and other marginalized groups.

Currently, communities of color are largely underrepresented in clinical trial participant populations. For example, according to the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research 2020 report, people of color made up 25% of the participant population of clinical trials.{2} As reported by the 2020 U.S. Census, people of color make up approximately 37.1% of the U.S. population.{3}

Further, certain conditions and diseases disproportionately affect specific groups of people. For example, there are higher incidences of multiple myeloma, colorectal cancer, triple-negative breast cancer, and prostate cancer in African Americans; of gastric cancer in Asian Americans and Pacific Islanders; and of cervical cancer in Hispanic and American Indian/Alaska Native women, yet these communities are underrepresented in clinical trial participant populations.{4}

Ultimately, clinical studies are an opportunity to obtain new, groundbreaking treatments, which is why it’s important these studies are accessible to everyone.

Historical Context and Present-Day Biases

The first step in finding solutions is understanding the inequities marginalized groups face, especially Black and Indigenous people, LGBTQIA communities, and lower socioeconomic populations. For example, there is a major lack of trust between Black Americans and the healthcare system due to historical exclusion and exploitation and present-day health inequities. Some of this sentiment is connected to the revelation that, from 1932 to 1972, researchers in the now-infamous Tuskegee syphilis clinical trial misled and withheld treatment from 399 Black men with syphilis. These people were told the researchers would cure syphilis, but the researchers never intended to treat them.{5}

Black Americans are less likely to receive the same quality care white, cisgender, heteronormative people receive.{6} According to a recent study, Black Americans are 22% less likely than white Americans to be treated for symptoms of pain.{7} There are many factors that contribute to the health disparities Black Americans and other communities of color face, including, but not limited to, systemic and institutional racism and socioeconomic barriers.

Additionally, LGBTQIA communities experience biases within the healthcare system. According to a recent survey, 37% of transgender respondents and 33% of nonbinary respondents reported having avoided medical treatment for fear of discrimination.{8}

There is a need among healthcare professionals and the clinical research industry for more cultural humility and biases training regarding race, ethnicity, sexual orientation, and gender identity. Moreover, people of a lower socioeconomic status encounter increased financial barriers to clinical trial participation. Indeed, while most clinical trials offer compensation for participating, the financial incentive for participation rarely, if ever, outweighs the financial cost of joining a trial for those who are hourly employees or need to pay for transportation. The cost of transportation, lodging, and time away from work can make participation in a clinical trial seem infeasible.

Another impediment to participation is the costs study participants must cover for childcare, pet care, or other domestic responsibilities, which may be an obstacle for people who are financially disadvantaged. Thus, the financial cost for joining a clinical trial disproportionately affects people experiencing economic disadvantages.

Manifold Solutions for a Complex Topic

While the FDA and the clinical research community are taking many steps to increase diversity and address inequities, the potential solutions are—and need to be—manifold, given the complexity of the issue.{9} One solution to increasing diversity and inclusivity in clinical research is improving diversity and inclusivity among healthcare professionals and those involved in healthcare research. Nationally, people of color make up only 14% of physicians, and 98% of senior managers in healthcare organizations are white.{10}

LGBTQIA members also have very little representation in healthcare and research; according to a recent study, approximately 8.8% of medical students graduating in 2019 identified with the LGBTQIA community.{11} More work needs to be done to include more people of color, LGBTQIA persons, and people of other underrepresented groups in leadership positions and patient-facing roles. As the healthcare industry continues to strive toward inclusivity, participants will feel a sense of trust and safety with physicians who have similar lived experiences to their own. Moreover, individuals communicating directly with participants should be trained in cultural empathy and biases when interacting with people of identities different from their own.

Another solution to increasing diversity in clinical trials is destigmatizing clinical research. To address clinical trial stigmatization, the clinical research community must build trust. That starts with the messaging around clinical trials. When recruiting patients for clinical trials, there needs to be a relatable voice speaking to potential participants through direct communication, posted flyers, social media, and other paid advertising to reduce mistrust and increase the understanding of trials and their value. Recruiting communication should be casual and use colloquial language, and the imagery must be appropriately representative of the patient population.

Visible partnerships need to be fostered over time between healthcare research organizations and underserved communities through community and advocacy group partnerships. For example, the Biden administration partnered with local organizations and leaders in Black and Brown communities to improve vaccination numbers. According to a recent analysis by the Kaiser Family Foundation, “the racial disparities in COVID-19 vaccinations have narrowed” since the start of the Biden administration’s plan.{12} For clinical studies, a similar plan may be beneficial when building trust with marginalized groups.

Additionally, research sites might consider incorporating an avenue for patients to provide feedback. According to The Deloitte Center for Health Solutions’ study, respondents noted they would appreciate and use a platform to provide anonymous feedback for their healthcare professionals.{13} In brief, there are many avenues to build trust between marginalized communities and healthcare professionals.

Further, there is still a lot to be done to increase accessibility. When pharmaceutical and biotechnology companies are selecting research sites, it’s important to consider the site’s location and the ease of travel or even parking for those with limited access to transportation. Also, wheelchair ramps, highly visible signage, and knowledgeable check-in staff can help with early-stage participation and participant retention throughout a clinical trial.

Lastly, biopharma businesses might consider implementing more research sites with researchers who speak multiple languages. It is also important to consider altering research sites’ hours to include nonbusiness hours for participants who cannot skip work due to financial or family obligations. Again, the issue and solutions are manifold, but it is a positive sign that many people in the clinical research industry are asking themselves and their companies how increases in diversity, equity, and inclusion in clinical trials can be brought to life.

Currently, the demographics gathered for study participants are nationality, race/ethnicity, age, and gender (and only male or female). To understand the industry’s progress, there must be a concerted effort to implement a comprehensive survey for all identities, especially to unpack intersectionality. With these data, the industry will be better prepared to improve inclusivity for everyone.

Conclusion

When it comes to people’s health and well-being, swift and impactful change is needed to save lives and reduce disparities in health across all communities, particularly for those who are disproportionately affected by health inequities. Fortunately, the healthcare and clinical research industries are on the path to addressing the issues of inaccessibility and building trust.

References

National Institute on Minority Health and Health Disparities. 2022. Diversity and Inclusion in Clinical Trials. https://www.nimhd.nih.gov/resources/understanding-health-disparities/diversity-and-inclusion-in-clinical-trials.html
Cavazzoni P, Anagnostiadis E, Lolic M. 2021. 2020 Drug Trials Snapshots Summary Report. U.S. Food and Drug Administration’s Center for Drug Evaluation and Research. https://www.fda.gov/media/145718/download
Quarshie M, Slack D. 2021 Census: US sees unprecedented multiracial growth, decline in the white population for first time in history. USA Today. https://www.usatoday.com/story/news/politics/2021/08/12/how-2020-census-change-how-we-look-america-what-expect/5493043001/
National Cancer Institute at the National Institutes of Health. 2022. Cancer Disparities. https://www.cancer.gov/about-cancer/understanding/disparities
Dembosky A. 2021. Stop Blaming Tuskegee, Critics Say. It’s Not An ‘Excuse’ For Current Medical Racism. National Public Radio. https://www.npr.org/sections/health-shots/2021/03/23/974059870/stop-blaming-tuskegee-critics-say-its-not-an-excuse-for-current-medical-racism
Hostetter M, Klein S. 2021. Understanding and Ameliorating Medical Mistrust Among Black Americans. The Commonwealth Fund. Transforming Care. https://doi.org/10.26099/9grt-2b21
Meghani SH, Eeeseung B, Gallagher RM. 2012. Time to take stock: a meta-analysis and systematic review of analgesic treatment disparities for pain in the United States. Pain Medicine 13(2):150–74. doi:10.1111/j.1526-4637.2011.01310.x
Daley ME. 2022. Center for Information and Study on Clinical Research Participation. Working Towards a More Inclusive Environment: Transgender and Non-Binary Participants in Clinical Research. https://www.ciscrp.org/working-towards-a-more-inclusive-environment-transgender-non-binary-participants-in-clinical-research/
U.S. Food and Drug Administration. 2022. Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-plans-improve-enrollment-participants-underrepresented-racial-and-ethnic-populations
Shimasaki S. 2013. The Colorado Trust. Health Equity and Racial and Ethnic Workforce Diversity: How to Address the Shortage of Racially and Ethnically Diverse Health Professionals. https://www.coloradotrust.org/wp-content/uploads/2015/03/CT_Workforce_Diversity_Brief_FINAL.pdf
Association of American Medical Colleges. 2019. Matriculating Student Questionnaire: 2019 All Schools Summary Report. https://www.aamc.org/system/files/2019-12/2019%20MSQ%20All%20Schools%20Summary%20Report.pdf
Simmons-Duffin S. 2022. The Biden administration will pay community groups to help boost trust in vaccines. National Public Radio. https://www.npr.org/2022/02/08/1079243098/community-groups-vaccine-outreach-funding
Read L, Korenda L, Nelson H. 2021. The Deloitte Center for Health Solutions. Rebuilding trust in health care: What do consumers want—and need—organizations to do? https://www2.deloitte.com/us/en/insights/industry/health-care/trust-in-health-care-system.html