Advancing Diversity in Clinical Trials

A Call to Action for Minority Health Month

As we observe Minority Health Month, we recognize the critical importance of diversity in clinical studies. By including underrepresented populations, we can address health disparities and ensure that medical advancements benefit all individuals, regardless of race, ethnicity, or socioeconomic background.

This year’s theme for Minority Health Month is “Be the Source for Better Health: Improving Health Outcomes Through Our Cultures, Communities, and Connections.” This theme resonates deeply with our mission at IMA Clinical Research. We understand that the unique environments, cultures, histories, and circumstances of racial and ethnic minority populations impact health. Therefore, IMA has actively worked with public health and community-based partners to provide quality, equitable, and culturally responsive care.

Over the last several years, we’ve launched multiple initiatives to empower underrepresented groups through community-centered innovations and partnerships with local leaders. The following are a few highlights that we feel helped us champion diversity in clinical research to ensure that medical advancements cater to the varied needs of all individuals.

Addressing Historical Imbalances in Clinical Trials

The underrepresentation of diverse populations in clinical trials reflects a narrative of inequality, disparities in access, and institutional bias. This imbalance hinders the accurate assessment of treatment efficacy across different demographic groups and limits our understanding of potential adverse reactions. Medications developed without proper representation can have unintended consequences

To address these challenges, clinics must become agents of change by rebuilding trust with disenfranchised communities and fostering a new narrative of inclusivity and empowerment. By establishing reciprocal relationships with community partners, clinics can offer resources and services that are typically difficult to access.

Partnering with Community Leaders in New Jersey to Improve Health Outcomes

Our clinical site in New Jersey faced the challenge of engaging the Black community for a COVID-19 vaccine study. Studies show that vaccine hesitancy is higher among Black Americans than any other ethnic group— contributing to lower vaccination rates. The widespread belief that vaccines are unnecessary and historical gaps in healthcare access significantly contributed to this reluctancy.

To address these community challenges, our site partnered with Minister Mary Phillips-Blackshear, a respected figure and leader of the Emmanuel Episcopal Church in New Jersey. Mary was passionate about her community’s well-being and especially concerned about vaccine hesitancy within her parish. Her personal experience of losing her brother to COVID-19 motivated her to act.

Mary became a crucial figure in the recruitment process, inspiring her congregation to utilize the services and resources available at the clinic. Church vehicles were used to mobilize her congregation, ensuring transportation was not a barrier to participation. Her involvement and evangelism resulted in a highly successful study. We exceeded enrollment estimates with our initial goal of bringing on 160 patients. With the local outreach efforts, the site enrolled 401 participants and built up a waiting list of more than 1,600.

Mary continued to be involved with the clinic beyond the study, creating “Your Brother’s Keeper” shirts to amplify the study’s message and promote health within the Black community. Her personal journey and community engagement efforts garnered statewide recognition, culminating in her selection as a Heart of BioNJ Honoree at the BioNJ’s 29th Annual Innovation Celebration.

Mary’s story exemplifies how IMA Clinical Research believes minority health outreach requires new and inventive approaches. Choosing respected and well-connected leaders who advocate for their community members can make a significant impact.

Empowering Patients to Make Informed Decisions About Their Care in Texas

Community health education can also make a difference in reaching minority communities. Our clinical research site in Austin, Texas, serves a predominantly low-income Hispanic population that faces significant health disparities. This population is particularly susceptible to metabolic dysfunction associated with steatohepatitis (MASH), a type of liver disease prevalent among middle-aged Hispanic adults with obesity, diabetes, and high cholesterol.

To address the unique needs of this community, we became a resource for health education and healthcare-related services. The site offered free diagnostic exams, lab work, and liver scans to identify individuals at higher risk for MASH. Patient education seminars were also conducted about lifestyle modifications, obesity, and fatty liver disease. Dental problems are widespread among MASH patients and those living in disadvantaged neighborhoods in Austin. To address this issue, the site also distributed free dental kits.

By providing free resources and services, our site established itself as a valuable treatment option for patients with poor access to healthcare. The emphasis on education and community support increased patient engagement and participation in clinical research studies.

Increasing Access to Clinical Trials with Mobile Research Units (MRUs) in New Mexico

Our clinical site in Albuquerque, New Mexico, faced challenges in engaging diverse communities and overcoming transportation barriers. The Hispanic population they served had limited access to transportation, making it difficult for them to participate in clinical trials.

With support from the sponsor, the site was able to use Mobile Research Units (MRUs) to address these challenges and forged strong partnerships with local community organizations. We organized screening events at various settings, including health fairs, assisted living facilities, and community centers. These events brought the study directly to the people, making research opportunities more transparent and accessible.

The site’s efforts to bring clinical trials to underserved communities resulted in improved recruitment and engagement. By actively participating in community events and using MRUs, we aimed to demonstrate our commitment to breaking down barriers and making healthcare more accessible. The site plans to continue these initiatives by collaborating with community partners and promoting diversity in clinical research.

Equitable Healthcare For All

At IMA Clinical Research, we are dedicated to improving diversity in clinical trials and ensuring equitable healthcare for all. Our partnerships with local leaders and community-centered initiatives have shown promising results in recruiting and engaging underrepresented populations. By empowering patients and building trust, we can bridge the gap in healthcare disparities and create a more inclusive and effective healthcare system.

Contact us today to learn more about our initiatives dedicated to advancing diversity and equity within clinical trials. Let’s collaborate toward a more inclusive future in healthcare.

References

• Roat C, Webber-Ritchey KJ, Spurlark RS, Lee YM. Black Americans Receiving the COVID-19 Vaccine and Effective Strategies to Overcome Barriers: An Integrative Literature Review. J Racial Ethn Health Disparities. 2022 Dec 5:1–11. doi: 10.1007/s40615-022-01437-w. Epub ahead of print. PMID: 36469286; PMCID: PMC9734369.
• Padamsee TJ, Bond RM, Dixon GN, et al. Changes in COVID-19 Vaccine Hesitancy Among Black and White Individuals in the US. JAMA Netw Open. 2022;5(1):e doi:10.1001/jamanetworkopen.2021.44470
• Latest data on COVID-19 vaccinations by Race/Ethnicity. (2022, July 14). KFF. https://www.kff.org/coronavirus-covid-19/issue-brief/latest-data-on-covid-19-vaccinations-by-race-ethnicity/
• Clark, L. T., M. D., Geday, M., Allen, A., Peter, S., Elmer, M., Hoy, K. D., Merck & Co., Inc. (2020, October 6). Increasing Diversity InClinical Trials: The Critical Role of Community Partnerships & Collaborations. Retrieved from: https://www.clinicalleader.com/doc/increasing-diversity-in-clinical-trials-the-critical-role-of-community-partnerships-collaborations-0001
• Riazi K, Swain MG, Congly SE, Kaplan GG, Shaheen AA. Race and Ethnicity in Non-Alcoholic Fatty Liver Disease (NAFLD): A Narrative Review. Nutrients. 2022 Oct 28;14(21):4556. doi: 10.3390/nu14214556. PMID: 36364818; PMCID: PMC9658200.