Considerations to Increase Diversity, Equity, and Inclusion in Clinical Research

The FDA guidance on diversity in clinical trials is a great step in increasing diversity, equity, and inclusion in clinical research.¹ However, some elements are not specifically addressed in the guidance that can advance diversity, equity, and inclusion in clinical research and trials. 

Location, location, location!

The location of research sites has a significant impact on diversity in recruitment for clinical research. Most research sites are in ex-urban areas that are not accessible to many rural patients without significant travel distance and time.²

Similarly, if the sites are not accessible by public transportation, that can create hardships for many urban or ex-urban/sub-urban patients without private transportation.³ Ideally, when partnering with research site, sponsors should evaluate the research sites’ location, catchment area an`d accessibility. This can be achieved by reviewing census track records which are publicly available for review. Some regions may be best served by multiple sites, even though the sites may seem in proximity, as the catchment areas may be wide and without much cross-over.

Getting there!

However, relocating clinical research sites is not as easy as providing transportation resources to patients. There are many avenues that can be used to achieve this: gas cards, bus and rail tickets, or even using ride-share apps for patient transportation to appointments and visits. These are ubiquitously used in medical settings and can be easily integrated into research procedures.⁴ Another area to emphasize, is that even if patients have access to private transportation, parking space may not be easily available at some sites, so parking arrangements should be made to ensure that patients driving to the site are not burdened.

Who has the time?

Research sites should have extended hours for patients who may work during the day or only can schedule visits on the weekends.⁵ This may also be true of patients who are dependent on caregivers or guardians for transportation or support during their visit. Telehealth visits, or even home visits, for certain study procedures may reduce the burden of travel and time constraints, but also could be costly and provide other limitations to study procedures such as privacy.⁶ Therefore, these measures should be used judiciously and only after a discussion with the patient and their caregivers regarding the limitations of this approach.

Do you speak my language?

Clinical research enrollment often includes only English-speaking patients, and rarely Spanish-speaking patients.⁷ However, there are various languages spoken by communities around the United States with varying prevalence. For example, in central Ohio, the third most common spoken language is Somali, followed by Mandarin and Arabic.⁸ Patients’ preferred languages should be included, not excluded, from research endeavors to ensure all study communications are understood and elements, such as informed consent, are truly ‘informed’. Research sites should have available interpretive services or preferably, a community representative research team that is multilingual and proficient in the languages prevalent in that community. Further, patient-facing research documents should be made available in languages prevalent in that community. This also places an onus on institutional review boards not to burden research sites with costly medical interpretation services but work on allowing available interpretive services in the community to interpret study documents.⁹

What about the children?

Even for studies not enrolling pediatric patients, consideration must be given to patients who care for children.¹⁰ For example, a breastfeeding mother may need to bring her newborn or infant to the visit, particularly if the visit will involve an extended time. Patients and families with multiple young children may benefit from telehealth visits or home visits to avoid any conflict with childcare availability.

Nobody is perfect, but the more we lessen the burden of research and consider everyday challenges that patients may face that preclude them from being involved in research, the more diverse recruitment becomes. Involvement in clinical research should not be a privilege available to some patients who can drive, take time off, have childcare, and speak English, but a potential path to care for everyone to choose.

References:

1. Enhancing the Diversity of Clinical Trial Populations : Eligibility Criteria, Enrollment Practices, and Trial Designs. Center for Drug Evaluation and Research; 2020.

2. Feyman Y, Provenzano F, David FS. Disparities in Clinical Trial Access Across US Urban Areas. JAMA Netw Open. 2020;3(2):e200172. doi:10.1001/jamanetworkopen.2020.0172

3. Rigatti M, DeGurian A, Albert SM. “Getting There”: Transportation as a Barrier to Research Participation among Older Adults. J Appl Gerontol. 2022;41(5):1321-1328. doi:10.1177/07334648211072537

4. Leavens ELS, Stevens EM, Brett EI, Molina N, Leffingwell TR, Wagener TL. Use of Rideshare Services to Increase Participant Recruitment and Retention in Research: Participant Perspectives. J Med Internet Res. 2019;21(4):e11166. doi:10.2196/11166

5. Diversifying Site Location, Trial Design, & Community Partnerships To Drive Diversity In Clinical Trials. Accessed February 24, 2024. https://www.clinicalleader.com/doc/diversifying-site-location-trial-design-community-partnerships-to-drive-diversity-in-clinical-trials-0001

6. Naik H, Palaniappan L, Ashley EA, Scott SA. Digital Health Applications for Pharmacogenetic Clinical Trials. Genes (Basel). 2020;11(11):1261. doi:10.3390/genes11111261

7. Roy M, Purington N, Liu M, Blayney DW, Kurian AW, Schapira L. Limited English Proficiency and Disparities in Health Care Engagement Among Patients With Breast Cancer. JCO Oncol Pract. 2021;17(12):e1837-e1845. doi:10.1200/OP.20.01093

8. Most Common Languages Spoken at Home in Greater Columbus and Surrounding Regions | Stacker. Accessed February 24, 2024. https://stacker.com/ohio/columbus/most-common-languages-spoken-home-greater-columbus-and-surrounding-regions

9. Velez MA, Glenn BA, Garcia-Jimenez M, et al. Consent document translation expense hinders inclusive clinical trial enrolment. Nature. 2023;620(7975):855-862. doi:10.1038/s41586-023-06382-0

10. Zgierska A, Gramly T, Prestayko N, et al. Transportation, Childcare, Lodging and Meals: Key for Participant Engagement and Inclusion of Historically Underrepresented Populations in the HEALthy Brain and Child Development Birth Cohort. Journal of Clinical and Translational Science. Published online February 12, 2024:1-22. doi:10.1017/cts.2024.4