Diverse Recruitment in Fast Enrolling Wearable Device Clinical Trials

Contributors: Diane Tran, System Executive Director, Community Health Equity and Engagement, M Health Fairview and Katherine Grannon, Community Health Equity Impact Manager, M Health Fairview

Improving clinical trial diversity is an ethical, scientific, and clinical priority. Federal regulators, industry sponsors, the National Institute of Health (NIH), academic journals, investigators, coordinators, and physicians agree with the importance of ensuring diverse participation in medical research. Not only will racially diverse research studies validate trial results across the population, but they are also important in building trust in the results and subsequent therapeutic adoption of the studied investigational product. A recent experiment reported that giving African American/Black patients study results from a racially representative trial increased their belief that the drug would be effective for them by 20%, without altering white patients’ perception of the medication¹.

Racial minority participation in clinical research projects continues to lag United States population trends. According to the US census, the white (non-Latine) population decreased from 72% in 2010, to 59% in 20222. The racial and ethnic minority population has increased to 41%. The FDA 2020 report states that 75% of clinical trial participants were white³, the last time the US population was 75% white was 2000. Clinical trial involvement by white participants has held steady at 75-76% for many years, while the percentage of non-white patients in the United States continues to increase. Our efforts to conduct representative research are underperforming and exhibiting a negative trend.

The Food and Drug Administration (FDA) and NIH recognize the importance of racially diverse clinical research. The FDA and NIH have diversity offices, policies, goals and reporting requirements. Both research regulators require sponsors to create race and ethnicity research recruitment plans. The NIH mandates as a condition of funding that research applications include goals for recruiting and plans for achieving diverse recruitment⁴. The FDA’s draft guidance recommends similar efforts and outlines the contents of a Race and Ethnicity Diversity Plan⁵ which sponsors should present to the FDA as part of the research planning process.

NIH and FDA documentation states that enrollment in research studies should be representative of the corresponding population. Racial diversity is particularly relevant when conducting clinical trials with wearable devices. Wearable devices incorporate a range of optical, photoplethysmogram (PPG), mechanical and transdermal biosensors that may be challenged by different skin types. Skin pigmentation differences across a diverse population can affect the performance of wearable devices. The FDA guidance states that “for studies of such devices, skin pigmentation data in a diverse population would be a relevant attribute to collect to inform the assessment of any differential effects”⁵ .

Wearable device sponsors recognize the importance of enrolling a diverse population into their clinical trials. The majority of recent wearable device study protocols include race, ethnicity and Fitzpatrick skin

type enrollment requirements alongside the traditional inclusion and exclusion criteria. The accelerated enrollment schedule that accompanies many wearable device studies is a challenge to sites, and is further exacerbated by racial enrollment requirements from communities experiencing health disparities that do not commonly participate in research programs.

Fairview Frontiers is a national leader in performing wearable device clinical trials. Fairview Frontiers is a division of Fairview Health Services, a health system that includes 142 locations, 100+ specialties, 36,000 providers and affiliates, and 2.1 million patients yearly. Fairview Frontiers was established in 2011 and has witnessed the increase in racial and ethnic recruitment goals in wearable device studies over the past several years. Fairview Frontiers has a near-perfect record for meeting enrollment deadlines; however, many of the enrollment goals were set prior to the industry sponsor shift in protocol mandated race and ethnicity goals. As such, the preponderance of enrolled patients were white. In order to meet the needs of wearable device sponsors and advance Fairview’s commitment to equity and inclusion, Fairview Frontiers established a collaboration with the M Health Fairview Center for Community Health Equity.

The M Health Fairview Center for Community Health Equity is an extension of the work being done by the Fairview Community Advancement⁶ team to support health equity and drive engagement and innovation for community wellbeing. The center opened in summer 2022 and is located within the Fairview Community Health and Wellness Hub⁷ in Saint Paul, Minnesota. In partnership with other organizations, the center brings forward community insight and priorities in order to advance its three key strategies of serving as a community innovation incubator, strengthening infrastructure for engagement and collaboration, and leading as an inclusive institution anchored in our communities. This approach ensures that the health system’s efforts to address the social determinants of health (health behaviors, as well as economic and social conditions that impact overall health) are relevant and responsive to our diverse and evolving communities in Minnesota.

The collaboration between Fairview Frontiers and the center began in July 2022 with the objective of applying equity-centered and culturally responsive approaches to research recruitment and outreach. An internal working group facilitated by the center was formed to identify common participation barriers in clinical trials and best practices for recruitment and engagement. Based on their findings, the team developed a plan to review and update current communication tools, such as MyChart messaging (the electronic portal used by patients to schedule appointments, communicate with their care team, and more). In addition, the group identified the need for short- and long-term recommendations to engage and strengthen trust with historically marginalized communities.

Assessment of research recruitment challenges.

The insight from the Fairview Community Advancement team was key to determining barriers to clinical trial participation for underrepresented communities. Specifically, cultural brokers⁸ provided their expertise and knowledge of their racial and ethnic communities, which also enabled the development of recommendations to improve outreach and recruitment strategies.

For the past six years, cultural brokers – full-time bilingual, bicultural Fairview employees who understand health and healing from their community’s perspective as well as that of mainstream culture – have been working with people in Minnesota’s diverse communities. Cultural brokers work in partnership with community organizations to connect people to healthcare services and other resources

like nutrition, financial support, and education. Serving as liaisons to local Karen, Hmong, Latine, African American, and Native American communities, they build bridges and assist people in navigating health, school, and other systems. At the same time, the cultural brokers strengthen community members’ abilities to navigate systems and advocate for themselves.

Based on the input from cultural brokers, the Community Advancement team, and a literature review process, the working group identified the most common challenges for underrepresented groups to participate in clinical research and proposed specific recommendations to address these issues. The main barriers are listed below:

• Mistrust in healthcare systems. This is a complex issue influenced by a combination of systemic, social, historical, and cultural factors⁹. The Community Advancement team advised that populations affected by systemic inequities may have concerns and understandable hesitation to engage and participate in clinical trials.
• Perception of safety and privacy. Populations of color and other marginalized groups may have concerns about safety and privacy during a clinical trial¹⁰. Based on their experience serving the community for years, the Community Advancement team and cultural brokers noted that this is especially true for the Latine undocumented population, who might be hesitant to disclose their personal information because they fear their immigration status will be shared with other public entities. Additionally, cultural brokers shared that this population may believe that, because undocumented immigrants are ineligible for most public health programs, they will be responsible for the financial expenses for any medical procedure conducted during the clinical trial.
• Lack of awareness and clarity of the main objective of clinical research. There is limited access in the general community to information about ongoing clinical trials. Additionally, the cultural brokers shared that the outreach materials developed often do not clearly communicate the purpose and importance of diversity in clinical research.
• Other accessibility issues. The team identified additional accessibility barriers to trust, enrollment, and participation in clinical trials. These include education level, technology literacy, and language barriers, as well as the lack of culturally responsive practices and ongoing community outreach.

Recommendation and implementation

Fairview Frontiers and the M Health Fairview Center for Community Health Equity partnered to increase diversity in several clinical trials involving wearable devices. The working group developed the following recommendations to improve clinical trial diversity.

1. Develop a culturally responsive recruitment strategy by reviewing the current communication tools and creating new ones that prioritize clear and culturally relevant messages. Based on the challenges listed above, the working group suggested different communication methods alleviate the potential concerns of people of color. Specific communication strategies in response to each barrier can be seen in Table 1.

Table 1

Mistrust	· Develop a new MyChart message, a postal letter, and a flyer addressing potential concerns. Clarify that the participant would receive continual guidance and support during the study.
Perception of Safety and Privacy	· The communication tools should ensure informed consent and adherence to privacy regulations. For example, the outreach materials utilized in this collaboration process stated that the patients’ personal information would only be shared with study team members and that no information would be collected without their consent. · The outreach materials also should provide a clear message about the study safety and activities performed during the clinical trial. For example, the time the first visit would take and the next steps afterward
Lack of clarity about the main objective of the study	· Develop a message explaining the benefit of participating in the clinical trial for the individual and their community (beyond the monetary incentive participants can receive.) Explain how their participation can improve the health and wellbeing of their communities.
Other accessibility issues	· Improve the readability of the outreach tools. For the clinical trials in collaboration with Fairview Frontiers, the team used the Flesch Kincaid Grade tool to ensure the flyer and the MyChart message had an accessible reading level of less than 8.0 (7th grade). Originally, the MyChart recruitment letter had a reading level of 11.9 (12th grade or college). · Translation of materials, if applicable, based on the focus population.

2. Collaborate with the Cultural Brokers to recruit potential participants

The working group partnered with the cultural brokers to recruit potential participants from the African American/ Black, Native American, and Latine communities. The role of the cultural broker in the research recruitment process was to be a trusted source that acted as a warm connection with the patients on the call list and responded compassionately to any hesitancy to participate due to past experiences or historical trauma. The participation of the cultural broker in the recruitment process opened an effective communication channel with patients feeling comfortable to ask questions about the trial and express concerns. Additionally, the cultural brokers utilized their social capital, promoting the flyer for both clinical trials among their networks and talking to community members and leaders about the research

3. Develop a strategy to follow up with participants and community members after the clinical trial concludes

The working group recommended the creation of a long-term strategy to follow up with the participants to strengthen the relationship with the community. The working group suggested specific actions to

sustain and create trust. For example, measure the level of satisfaction after participating in the study by including a question or survey about their experience, design a thank you card and/or event for the participants, and plan an event at the M Health Fairview Center for Community Health Equity event and education center highlighting the clinical research and how it benefits our communities’ wellbeing and health.

Implementation of the M Health Fairview Center for Community Health Equity recommendations and direct support by the cultural brokers have yielded both positive and educational results. Under the direction of the working group facilitated by the center, new recruitment materials were developed and approved by the appropriate IRB. The cultural brokers spoke with community leaders and shared the message of research in local community establishments. The Fairview Frontiers recruitment office received more inquiries from minority patients than they had ever experienced.

In 2022, the Fairview Frontiers department enrolled 838 patients into a portfolio of clinical trials. A sub-group analysis indicates that Fairview Frontiers enrolled 130 non-white patients during this period. The result of 15.5% non-white patients compares with a non-white Minnesota population of 22.4%. The collaboration with M Health Fairview Center for Community Health Equity provided significant improvements in 2023. Fairview Frontiers enrolled 600 patients into a large portfolio of studies during January – April 2023. A similar sub-group analysis demonstrates that 203 non-white patients were enrolled, representing 33.8% of enrolled patients. For the first time, Fairview Frontiers enrolled a non-white overrepresentation of the state’s population. The improvement from 15.5% to 33.8% is directly attributed to the M Health Fairview Center for Community Health Equity collaboration.

Table 2

Conclusion

Enrolling a diverse group of patients into clinical trials is a fundamental goal in contemporary research for clinical trial regulators, sponsors and sites. Enrolling patients from underrepresented and marginalized communities is difficult and requires a multifaceted strategy. Collaborations with trusted experts in community engagement and health equity is a successful strategy in planning non-white patient recruitment and implementing community-based recruitment strategies.

---

References

¹Schwartz A, Alsan M, Morris A, Halpern S, Why Diverse Clinical Trial Participation Matters, N Engl J ed, 2023, 388: 1252-1254

²United States Census Bureau, Quick Facts, www.census.gov/quickfacts/fact/table/US/PST045222

³US Food and Drug Administration, 2020 Drug Trials Snapshot, Feb 2021, https://www.fda.gov/media/145718/download.

⁴NIH Clinical Trial Diversity Act of 2022.

⁵US Food and Drug Administration, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials, Draft Guidance, April 2022.

⁶M Health Fairview. n.d. Our community commitment. https://mhealthfairview.org/About-Us/health-equity/our-community-commitment.

⁷Fairview Health Services . n.d. Fairview Community Health and Wellness Hub. https://www.fairview.org/east-metro/wellness-hub.

⁸Health Fairview. 2023. Celebrating five years and counting of M Health Fairview cultural brokers program. January 5th. https://mhealthfairview.org/blog/cultural-brokers-program-celebrates-fifth-anniversary.

⁹Luis F Graham, Lamont Scott, Erus Lopeyok, Henry Douglas, Aline Gubrium, and David Buchanan. 2018. “Outreach Strategies to Recruit Low-Income African American Men to Participate in Health Promotion Programs and Research: Lessons From the Men of Color Health Awareness (MOCHA) Project.” American Journal of Men’s Health 1307-1316.

¹⁰India J. Onelas, Thespina J Yamanis, and Raymond A. Ruiz. 2020. “The Health of Undocumented Latinx Immigrants: What we know and future directions .” Annual Review of Public Health 289-308.