Clinical trials should be underpinned by diversity, but are you considering more than what’s obvious?
The current focus on diversity in clinical trials is too limited, often concentrating on visible aspects of diversity and overlooking other crucial factors that impact ability and/or desire to participate in a clinical trial. When study participants can’t afford to get to a site, understand study materials, or access digital resources, solely focusing on age, race, and gender will not fully support inclusive and diverse research.
It’s easy to use data inaccessibility as a reason to limit diversity and inclusion plans to race, ethnicity, age, and gender. However, this narrowed approach to diversity in research perpetuates leakage points in recruitment and retention and is riddled with missed opportunities.
Missing the unusual suspects? Miss them…miss out
Broader dimensions of diversity, such as education, culture, religious beliefs, family dynamics, or health literacy, play an important role in the decision-making process for potential study participants.1,2 They not only influence interest in joining a study, but also impact the ability to actively engage in one to completion. Despite the effect on recruitment and retention, those dimensions are overshadowed by constructs of diversity that focus on what can be seen and collected.
Diversity and inclusion initiatives and regulatory guidance focus on self-reported demographics of race, ethnicity, age, and gender.3,4 Additionally, attempts to enhance inclusion are constrained by the data used to evaluate diversity in studies.5 This leaves secondary dimensions of diversity (what is not always seen) on the fringes of recruitment and retention planning, further marginalizing the marginalized. While starting somewhere is better than not starting at all, we can do better.
Consider pregnant or lactating individuals, those who have limited mobility, or are of lower socioeconomic status.6–11 Individuals within these groups may be a part of the patient population for any given disease, yet they are too often underrepresented in clinical studies. If dimensions of diversity were more broadly considered, the unique needs and experiences of various underrepresented groups could be identified, collected, and incorporated in early phases of study planning and design. This could then lead to greater recruitment potential, increased rates of retention, and ultimately greater generalizability of study results.3
It is incumbent on us leaders in the clinical research ecosystem, those who contribute to the design and operationalization of clinical studies, to broaden our definition of representation and our thinking on the evidence needed to support it.
It is time to transform the way we perceive diversity in research.
There is a need to look beyond historically marginalized groups and those with more readily available demographic data based on socio-geographic constructs, to include other populations that are often overlooked and underrepresented. Leaders should endeavor to use this as a starting point, and then seek out, plan for, and integrate innovative means to capture and analyze new data points to tell the untold story. In that story lies answers to recruitment and retention challenges. In those answers are opportunities to facilitate inclusive recruitment strategies that support the broader patient population.
Are you ready to redefine representation in your clinical trial?
We invite you to join us as we explore the stories of underrepresented patient groups. Their stories will close gaps in knowledge, uncover barriers to participation, and inform strategies to create equitable and accessible studies as we strive to ignite change and redefine clinical study representation. Stay tuned…
Sexual and gender minority populations—in a world where constructs surrounding sex and gender are ever evolving, has the world of clinical trials considered the inevitable shift/change in patient demographics in the next 10–20 years? Let’s not wait to start planning.
Neurodiversity—not only is there a need for a greater number of studies for the neurodivergent community, but also for inclusion in studies in other therapeutic areas. Join us as we are guided through a discussion on neurodivergence and are encouraged to reconsider inclusion from a perspective that is not “neurotypical.”
Cultural and religious beliefs—cultural mosaic or melting pot: which best describes how cultural differences and religious beliefs are viewed and managed in clinical research? Join us as we explore how one’s background, faith, and religious practices drive perceptions, acceptance, and actions toward clinical trials as a treatment option.
Digital equity—regardless of socioeconomic status, all should have equal access to modern digital technology, the internet, and digital literacy training. It ensures that everyone can fully participate in the digital world, including having the skills and resources necessary to use digital technology effectively. This is crucial in today’s world where much of education, work, and communication happens online.
REFERENCES
1. Swihart DL, Yarrarapu SNS, Martin RL. Cultural Religious Competence in Clinical Practice. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan–. Available at: https://www.ncbi.nlm.nih.gov/b....
2. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Roundtable on Health Literacy; French MG, Wojtowicz A, editors. Health Literacy in Clinical Research: Practice and Impact: Proceedings of a Workshop. Washington (DC): National Academies Press (US); 2020 May 28. 3, Embedding Health Literacy in Clinical Trials to Improve Recruitment and Retention. Available at: https://www.ncbi.nlm.nih.gov/b....
3. US Food and Drug Administration. Drug Trials Snapshots Summary Report. 2021. Available at: https://www.fda.gov/media/145718/download. Accessed August 2024.
4. Gilchrist SC et al. Research goes red: early experience with a participant-centric registry. Circ Res 2022;130:343–351.
5. Washington V et al. Diversity, equity, and inclusion in clinical research: a path toward precision health for everyone. Clin Pharmacol Ther 2023;113:575–584.
6. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Forum on Drug Discovery, Development, and Translation; Shore C, March A, Wizemann T, editors. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington (DC): National Academies Press (US); 2022 Dec 15. Available at: https://www.ncbi.nlm.nih.gov/b....
7. Meyers AR, Andresen EM. Enabling our instruments: accommodation, universal design, and access to participation in research. Arch Phys Med Rehabil 2000;81(12 Suppl 2):S5–S9.
8. Feldman MA et al. Inclusion of children with disabilities in mainstream child development research. Disabil Soc 2013;28:997–1011.
9. Krahn GL et al. Persons with disabilities as an unrecognized health disparity population. Am J Public Health 2015;105(Suppl 2):S198–S206.
10. Williams AS, Moore SM. Universal design of research: inclusion of persons with disabilities in mainstream biomedical studies. Sci Transl Med 2011;3:82cm12.
11. Heiat A et al. Representation of the elderly, women, and minorities in heart failure clinical trials. Arch Intern Med 2002;162:1682–1688.