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Community Engagement and Investment

Panelists explored strategies for improving diversity and inclusion in clinical trials, including approaches to overcome the challenges hindering representative participation and to reduce the burdens of conducting inclusive trials. The session was moderated by Martin Mendoza, chief health equity officer at Centers for Medicare & Medicaid Services (CMS) and director of the CMS Office of Minority Health.

ESTABLISHING EQUITABLE RESEARCH PARTNERSHIPS

Karriem Watson, chief engagement officer at the National Institutes of Health (NIH) All of Us Research Program, shared that it has become “the world’s largest, most diverse genomic dataset” with more than 48 percent of participants self-identifying with a race or ethnicity that is underrepresented in biomedical research, and even higher numbers for specific research areas. He attributed the increase over time in diverse participation to improved trustworthiness of the organization, which is earned through “true community engagement and building relationships.”

Watson emphasized the importance of using appropriate wording. Residents of Tuskegee, Alabama, have asked to avoid “Tuskegee experiment,” since they did not ask for that study. Using the full name of the project, the “United States Public Health Service (USPHS) Study of Untreated Syphilis in the African American Male,”¹ helps tell the history of that experience.

After 5 years of relationship building with the community of Tuskegee, community members got together and sent Watson an email saying they were ready to be an equitable partner in All of Us. He made clear that, as opposed to pushing for their enrollment at the start of the engagement process, “when they said they were ready, we then got ready” to enroll. All of Us recently held a convening that included over 300 community members, including descendants from the USPHS study. Participants in that convening told Watson that community members would be monitoring the program to encourage accountability.

Tuskegee University, a historically black university, is an All of Us partner. Charlotte Morris, then president of the University, informed Watson that they lack the resources to be fully engaged with the All of Us goals. This hinders the ability of the University to be an equitable partner, and instead places them in the position of being a subawardee. She said that additional funding can help the University be an equitable partner; in other words, All of Us needs to “do better.” Watson noted that, while All of Us was one of the first NIH programs to “put funds in the hands of community partners,” there is still more work to be done to promote community engagement and community involvement.

Doing better, Watson concluded, means establishing equitable research partnerships and investing in communities. This includes the following:

• developing a clinical research workforce that better reflects the populations most impacted by the disease or condition being studied;

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¹ Now referred to as the “USPHS Untreated Syphilis Study at Tuskegee.” See https://www.cdc.gov/tuskegee/timeline.htm (accessed September 9, 2024).

• approaching community engagement as a true science; and
• ensuring all who want to participate have access to clinical research.

While “justified medical mistrust” remains an issue to be addressed, Watson said reasons underrepresented populations do not participate in clinical studies also include a lack of awareness of trials, lack of access to trials, and inclusion criteria that may exclude the population that bears the greatest burden of the disease.

RELATIONSHIPS AND RECIPROCITY

Ralph Cammack, director of research at Wabanaki Public Health and Wellness (WPHW), discussed the importance of building meaningful relationships with communities when conducting clinical trials, which includes involving communities in the research process from the beginning. WPHW² serves the Wabanaki communities of Maine, including the tribal communities of the Passamaquoddy, Penobscot, Mi’kmaq, and Maliseet, “from birth until elders.” Cammack emphasized the importance of reciprocity, which can be a critical element of successful community-based research. However, approaching communities in a meaningful way might be hard given the long history of mistrust in research due to past and ongoing injustices. It takes time to build meaningful relationships; missteps can set the clock back to the start. He encouraged continually maintaining relationships with the community, as well as tailoring approaches to relationship management and capacity creation for each community. WPHW is a member of the Research Electronic Data Capture (REDCap) Consortium, a clinical research data management platform to share expertise between organizations to support basic science research studies, clinical trial data collection, patient questionnaires, clinical decision support, and operational support.³ However, Cammack noted that infrastructure barriers, such as limited access to computers and the Internet, require carefully thought-out approaches to engage communities, particularly when it comes to health data. One consideration is making sure that data are returned to participants in an understandable form. He said communities can make “meaningful change” when they “own their own data.”

Using appropriate terminology can help combat what the Urban Indian Health Institute calls the “deficit narrative.” Focusing on deficits can have negative effects on how communities perceive themselves. WPHW is working to build community capacity through strength-based approaches—recognizing and building on positive attributes—rather than focusing on

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² See https://wabanakiphw.org (accessed September 9, 2024).

³ Harris, 2019. See https://doi.org/10.1016/j.jbi.2019.103208 (accessed September 9, 2024).

deficits. One example is focusing on positive childhood experiences to help build resilience in children.

Cammack emphasized that “words do matter.” For example, community members who are conducting interviews for a study of Alzheimer’s disease and dementia are called “community researchers” rather than “community interviewers.” Cammack pointed out that “our people were the first researchers of that land, the first evaluators. We’ve been here for thousands and thousands of years.”

COMMUNITY HEALTH THROUGH CHURCH INITIATIVES

Matthew Watley, senior pastor at Kingdom Fellowship AME Church in Calverton, MD, described some of the support services the church provides to the community to help address social determinants of health, including a food pantry, waiting areas for children, and health care services provided via a memorandum of understanding with Holy Cross Hospital. The church was also involved in clinical trials during the COVID-19 pandemic. Watley described how it, working with partners, developed and distributed a media kit through clergy networks across the country to raise awareness among African Americans of the importance of being vaccinated. He noted that churches are considered trusted and credible sources of information within communities, which can help overcome medical mistrust in the African American community due to incidents such as the USPHS Untreated Syphilis Study at Tuskegee.

The barriers to entry for community-serving organizations to engage in partnerships need to be lowered, said Watley. Many small organizations, including faith-based groups, do not have the resources or staff to complete the numerous applications and attend the multiple meetings that are standard business practice for government, pharmaceutical companies, or other large institutions. Partnerships should not be transactional, patronizing, or insensitive. That can include tailoring them to the resources and operational capabilities of community organizations. He concluded, “Let’s come up with action plans and business relationships that allow everyone to enter in. For all the resources to be pooled at the top of the stream and for us to still receive trickles at the bottom but be responsible for [trying] to change the numbers on diversity” is a key issue.

SUSTAINABLE COMMUNITY ENGAGEMENT

Brian Rivers, director of the Cancer Health Equity Institute at the Morehouse School of Medicine, framed his remarks around the goal of “how do we better engage our communities, especially those communities whose voices have been masked, whose voices have been suppressed, or

whose voices have not really been lauded and respected and regarded.” He began by acknowledging the work of Edith Mitchell and Worta McCaskill-Stevens as foundational individuals for Morehouse’s current efforts. Mitchell advanced clinical trial participation and expansion of cancer screening services through partnerships with community health providers, while McCaskill-Stevens worked with the National Cancer Institute (NCI) to develop cooperative initiatives to advance clinical research in community oncology and prevention trials.

Rivers emphasized the importance of showing up in person to meet with community members. Building trust and sustainable relationships with communities “demands high touch, a lot of meetings, a lot of dinners,” he said. It also takes time to build meaningful relationships. For example, Morehouse has spent 18 years creating relationships with communities in Macon and Bullock counties to build the local trust.

Rivers highlighted several ongoing initiatives to advance equitable clinical research in the United States, including the U.S. Food and Drug Administration (FDA) diversity action plans; the Community Partnerships to Advance Science for Society Program,⁴ which funds community-based organizations to address structural determinants of health; and Partnerships to Advance Cancer Health Equity (PACHE) program of the NCI Center to Reduce Cancer Health Disparities.⁵ Initiatives also focus on workforce diversity, including the Robert Winn Career Development Award,⁶ which supports training for early-stage physicians to conduct clinical research including trial implementation and evaluation. The awardees, who are from diverse backgrounds, also receive training on the science of community engagement through workshops held by Morehouse and ongoing mentoring after they return to their communities.

A ROLE FOR CHANGEMAKERS

When it comes to diversity in clinical trials, Quita Highsmith, vice president and chief diversity officer at Genentech, stated that “we don’t need any more allies. What we need are changemakers.” She acknowledged that others may not agree with her definition, but she went on to say that from her perspective, an ally is someone who agrees that a problem exists and that something should be done, but when it is time for action, they may end up as a bystander. A changemaker is someone who is ready to be disruptive and take a stand. She described her own experience stepping up within her

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⁴ See https://commonfund.nih.gov/compass (accessed September 9, 2024).

⁵ See https://www.cancer.gov/about-nci/organization/crchd/diversity-training/pache (accessed September 9, 2024).

⁶ See https://diversityinclinicaltrials.org/winn-cda/ (accessed September 9, 2024).

company to challenge the lack of diversity for two studies released in 2016 in which White participants made up 94 percent and 91 percent of trial populations. Beginning in 2025, FDA will require product sponsors to submit a diversity action plan to help improve enrollment of underrepresented populations in clinical trials.⁷ Some sponsors have begun doing so ahead of the mandate; Highsmith shared that Genentech is leading the way with 26 diversity plans already submitted.

INCLUSIVE RESEARCH BEYOND ENROLLMENT

Watson shared that one of the first considerations for community engagement is changing the definition of success. Clinical trial enrollment is only one metric. Other valuable outcomes may include increased awareness or interest from community members, training opportunities, fostering a trusted partnership, or other non-transactional relationship-building measures. Watson emphasized the importance of being trustworthy in the eyes of the community. One way to build trust is by having resources and partnerships that last beyond the duration of an individual program; research teams should not take a “helicopter approach” to community engagement.

Highsmith raised the point that few communities of color have access to genomic testing. The majority of sequencing data in genome-wide association studies are based on White individuals of European ancestry (95.5 percent); data from Black and Hispanic persons account for 0.65 and 0.34 percent, respectively, of worldwide participants.⁸ She noted that programs like All of Us are critical to overcome this discrepancy. Highsmith further emphasized the need to clearly explain to people, in terms they can understand, why participating in genome sequencing is important for their health and how their data will be used and protected. For example, many people harbor fears that government or law enforcement might use their DNA samples or sequencing data against them. Participants should be reassured that genetic information will not be shared in other government databases or used for purposes other than clinical trials. Researchers should

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⁷ The diversity action plans required under FDORA (Food and Drug Omnibus Reform Act) are discussed in Chapters 5 and 6. The draft guidance was issued on issued on June 26, 2024 (FDA, 2024b). The requirement will become effective 180 days after the final guidance is published. See https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-action-plans-improve-enrollment-participants-underrepresented-populations-clinical-studies (accessed September 9, 2024).

⁸ As of August 22, 2024. Data obtained from the GWAS (Genome-wide Association Study) Diversity Monitor (Mills and Rahal, 2020). “Black” refers to persons of African, African American, or Afro-Caribbean descent. “Hispanic” refers to persons of Hispanic or Latin American descent. See https://gwasdiversitymonitor.com/ (accessed September 9, 2024).

“ask the questions and get down to the level of education and community understanding so that then they’re not scared of new things,” she said.

Rivers agreed and said Morehouse’s qualitative research on barriers to clinical trial participation has found that members of underserved communities often express particular concern about the bioethical considerations of research participation. Morehouse has developed tools to increase public understanding of the value to both individuals and their communities. This can help reduce fears about personal safety in clinical trials and data confidentiality. For example, Morehouse is implementing a Clinical Trials and Cancer Genomic Education Program in partnership with the University of Alabama.⁹ One element is a multilevel navigation program; navigators help connect individuals with appropriate trials while also considering social determinants of health that can present barriers to participation (e.g., access to a clinical site, childcare, time off from work). The program was expanded to nonclinical settings because minority patients are often seen in community locations. Another component is video technology to explain trial-related topics, such as voluntary participation, consent, and biorepositories.

These approaches involve strategic investment of resources to create capacity in the trusted community organizations where people gather and receive information, Rivers said, including churches and other faith communities, barbershops and beauty salons, and veterans’ organizations. Rivers concurred with Watson that community organizations that support diverse enrollment in clinical trials should be recognized and compensated as partners, not just subawardees. People pay attention to the news and notice when “the grant was $5 million” but a church is offered “$500 to attend three meetings.” He noted that “when the dollars flow, capacity is developed, and the needle will move.”

THE ROLE OF FAITH-BASED ORGANIZATIONS

Mendoza asked panelists to comment specifically on the role of churches and faith-based organizations in engaging diverse populations in clinical research

Watley said the church serves many functions beyond Sunday worship in the African American community. Kingdom Fellowship AME Church partners with other organizations (e.g., counties, law enforcement, schools) to provide services spanning health, education, economic empowerment, and other areas of community need. The greater community that is served includes Hispanic, African, and African American communities and a large

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⁹ See https://reporter.nih.gov/search/PXx0DMwHZ0S_M_3qPFC7Mg/project-details/10672347 (accessed September 9, 2024).

undocumented community. Because of the church’s significant and sustained presence in the community, “everyone knows one another” and there is “a huge level of trust,” Watley said. Networks of churches that have similar credibility in their communities are willing partners in driving increased diversity and inclusion in clinical trials. Watley noted that one consideration for those who want to work with churches is maintaining a “sustained presence” as opposed to a one-off activity.

Rivers agreed that churches and faith-based organizations offer “a tremendous opportunity for engagement.” He described receiving a $100,000 supplemental award from NIH during the pandemic to help address “the breakdowns in community capacities to actually participate effectively in clinical research.” After consultation with community partners, Morehouse issued $10,000 microgrants to 10 churches in the Albany, Georgia, area, where disparities in COVID-19 outcomes were substantial. This facilitated education and awareness campaigns and training health ministry leaders as navigators to connect community members to local health services and opportunities to participate in clinical research. This infrastructure is still in place and has been leveraged for other studies (e.g., the Prostate Cancer Precision Prevention Program). This model has been sustainable, he said, because Morehouse invested directly in building the capacity of the community “to be meaningful participants in the clinical research continuum.” These partnerships can also be resources for new investigators so that they are not creating new relationships from the ground up.

Watson described faith-based settings as safe spaces where community members can ask questions and receive culturally relevant, useful information. He described a recent “return of value event” at a church where he discussed the value of genetic research for individuals and communities. A community member told Watson they needed more than just receiving their genetic information; they needed to know what to do with it. Watson explained how All of Us provides free access to genetic counselors so participants can understand their results and be prepared to talk to their health care providers about them. Because research is different from clinical care, All of Us will also provide free confirmatory testing for findings of potential clinical importance. He pointed to his work in Tuskegee as an example of partnering with faith-based organizations as enrollment sites because they are organizations with a “trusted legacy.” Overall, Watson said that “we need more safe spaces, cultural connection where we can talk about how do we get information back to community in ways and spaces and places where they can process that information.”

Watson also pointed out that faith-based organizations should include spirituality and cultural connectedness, which he associated with tribal engagement. A tribal leader once told him that “research moves at the speed of trust.” Engagement means being in the community in person, not

just over Zoom. Watson was told “our elders need to see you, they need to touch you, they need to feel your spirit. They need to get to know you, and you have to show up.” Similarly, Cammack shared that before tribal elders and others in the community will share their stories, they might want to know: “Who are you? Who is your family? Why are you here?”

ADDITIONAL STRATEGIES FOR PROMOTING EQUITABLE PARTICIPATION IN CLINICAL TRIALS

Gwen Darien of the Patient Advocate Foundation said a key impediment to diverse participation in clinical trials is that clinicians do not ask minority patients. Rivers agreed and said information from focus groups and interviews at a safety net hospital in Atlanta indicated that physicians were making judgments, without any evidence, about who could not afford to participate. Morehouse has implemented a clinical trial navigation program and patient resource center at this hospital to promote equitable trial participation through to countering the impact of provider attitudes and preconceived notions about patient interest and ability to participate. Rivers reiterated the need for partnerships and investment in community institutions that serve minority populations, such as safety net hospitals that often have limited resources.

Tasha B. Moses, of Strategic Management Services, LLC, spoke about a number of strategies to increase broad participation in clinical trials. First, Moses suggested that policies should do more than require engagement with faith and other community-based organizations; they should include considerations for equitable partnerships, such as appropriate funding and compensation. Moses also offered that strategic, generational change begins with the youth. One approach is to engage high school students, possibly through youth-serving community-based organizations, in health literacy conversations, such as the importance of genetic screening. Students can influence their families by sharing that information at home. Similarly, Rivers shared that Melissa Davis at Morehouse is beginning a multigenerational educational program to address health inequities in cancer genomics, which includes training high school students to be community health navigators who can inform family members about the value of genomic testing and participation in clinical trials.¹⁰

Moses also suggested developing ambassador programs for clinical trials. One model could be a formalized program in which trial participants share their experiences with communities. Furthermore, she suggested that researchers can make better use of patient advisory groups through

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¹⁰ See https://www.msm.edu/RSSFeedArticles/2024/March/Cancer-Grand-Challenges--Award.php (accessed September 9, 2024).

engaging in meaningful conversation, listening to their advice, and integrating them into discussions of how best to communicate trial data to the community (instead of simply assembling a group to meet a trial requirement). For example, Moses works in communities that can have literacy rates of less than 30 percent; people in those communities might not understand the medical discussion and can feel demeaned because of this, which can hinder trust. Community members should be “involved in all of the processes so you’re educating them and enlightening them on what’s happening and truly treating them like they’re partners.”

Watley added that many people, for better or worse, rely on social media as their primary source of information. However, social media influencers are not necessarily equipped to impart key health information. The challenge in leveraging social media is “to find somebody who has enough influence to reach, but has enough capacity to send the right message,” he said.

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