Multisectoral Collaborations to Increase Recruitment and Retention of Diverse Older Adults in Biomedical Research

Abstract

Background

Older adults, especially minoritized racial-ethnic groups, are historically underrepresented in biomedical research. This study summarizes the development and assesses the impact of a review board involving a multisectoral group of stakeholders with the goal of increasing the diversity of older adults in biomedical research.

Methods

A 25-member board of community members, caregivers, researchers, and clinicians from Upstate New York reviewed 3 projects presented by researchers, clinician-scientists, and a pharmaceutical company between January and December 2022. For each biomedical research project, the reviews provided guidance to increase the recruitment and retention of diverse older adults engaged in the study. Review board members and presenters completed surveys to provide feedback on their experience in this collaboration.

Results

There was consistent positive feedback from all members and presenters. From member surveys, feedback trended positive in meetings throughout the year. Community members and caregivers initially indicated discomfort in expressing their views; however, these concerns subsided over time. Presenters had a very positive experience in the review board’s impact on their recruitment strategy and study design, and therefore very likely to use this service again. Recommendations were made to adjust membership criteria, presentation format, and funding to sustain this effort.

Conclusions

Lack of diversity for older adults represented in biomedical research contributes to ethical and generalizability ramifications. The positive feedback from all stakeholders in our multisectoral board of community members, caregivers, researchers, and clinicians offers a promising structure for developing similar strategies to increase diversity within and beyond biomedical aging research in other communities.

Older adults, especially from minoritized racial-ethnic groups, have traditionally been underrepresented and excluded from various aspects of research. Multiple studies have highlighted that minoritized racial-ethnic groups lack representation in biomedical aging research funded by the National Institutes of Health (NIH) (1–3). These inclusion gaps are conspicuous, particularly in the study of Alzheimer’s disease and related dementias, other neurodegenerative diseases, cancer, and diabetes. White adults represent an average of 70%–80% of the study cohorts compared to single-digit percentages among Black and Hispanic adults (1). In 2020, national headlines elucidated this disparity by drawing attention to the controversy around the U.S. Food and Drug Administration (FDA) approval of Aducanumab and the study’s inappropriately small number of minoritized racial-ethnic groups enrolled to treat Alzheimer’s (4). More broadly, White study participants account for the overrepresentative majority of those enrolled in biomedical randomized clinical trials (5,6). As a result, research questions related to disease etiology, prevention, and treatment are generalizable for predominantly White and non-Hispanic individuals. This is of concern because older minoritized racial-ethnic groups have a disproportionately higher risk for many comorbidities including diabetes, heart disease, and hypertension (7).

Inclusive recruitment strategies and representation are a public health imperative that merits attention. In the pursuit of this public health goal, one would find biomedical-related inclusivity and partnerships, at all stages, as a vital centerpiece. By dispelling diversity, equity, and inclusion misconceptions within the biomedical industry, a shared understanding and united mission can be achieved (8). Beyond the respective ethical and moral dimensions, financial pragmatism is a mutual concern for all stakeholders. If left unaddressed, the projected U.S. healthcare cost is likely to rise from $320 billion in 2022 to $1 trillion in 2040 (9). Early implementation of diverse recruitment strategies can mitigate long-term costs by ensuring accurate decision making at varying levels, reducing the need for expensive pivotal studies on ineffective treatments (8,10). Greater scientific inclusivity would lead to more representative clinical trials, improved study validity, and even a widened market opportunity. These inclusive interventions have the potential to save human lives and taxpayer dollars incurred by healthcare disparities.

On a deeper level, a multitude of motivations and tensions perpetuate among the stakeholders in biomedical research for older adults. For instance, consumers and advocates in the lay community are motivated by altruism, such as finding a cure to a disease (11,12), but many minoritized racial-ethnic community members distrust the medical, research, and pharmaceutical communities from historical injustices (eg, Tuskegee Study) and persistent discrimination in healthcare settings (13,14). Research and clinical institutions are motivated to produce high-impact research but at minimal financial cost and time investment. Pharmaceutical companies are motivated to develop profitable drugs for shareholders, but also pressured to do public good by enacting fair drug prices and developing pharmaceutical solutions to devastating rare diseases—that may not be profitable (15).

Despite these differences across each sector, stakeholders share the common goal of wanting to achieve optimal health for all populations. Nevertheless, due to varying motivations and tensions across the lay community, researchers, clinicians, and pharmaceutical companies, the current interactions are limited and ineffective in accomplishing this shared goal. Thus, this paper aims to address this critical issue via 3 distinct objectives. First, it describes the innovative development of a review board involving a multisectoral group of stakeholders with the express aim of enhancing the diversity of older adults in biomedical research. This approach is novel as it engages diverse stakeholders in a coordinated effort to address a complex problem. Second, the paper shares the results of this review board, offering insights from the perspectives of each sector, an approach rarely explored in prior studies. Third, the paper discusses the strengths, weaknesses, and opportunities of this novel approach, outlining its potential to substantially increase research diversity within and beyond biomedical aging research. These objectives underscore the original contributions and novel insights of this study, emphasizing the significance and relevance of the research presented here.

Method

Community Research Recruitment Accelerator Overview

Our Community Research Recruitment Accelerator (CRRA), which we describe in this current study, mimics aspects of community-based participatory research (CBPR). Here, community members have a voice and become deeply engaged in the scientific research process, such as in conceptualizing the study and providing recommendations for the study design. CBPR is often a valuable approach as it frequently engages a diverse group of community members who may have been historically disenfranchised in research that may not have outcomes relevant or meaningful to a community (16). Similarly, our CRRA is composed of caregivers, community leaders including faith-based organizations, clinical service providers, and researchers. This collective was developed so that researchers can receive guidance from the CRRA relative to increasing the diversity of minoritized racial-ethnic groups in all stages of research development, from study conceptualization to dissemination. Although the CRRA reviews research studies broadly in the field of aging, the initial focus was on studies related to cognitive impairment due to the elevated risk for older populations.

CRRA Recruitment and Cohesion

The composition of the CRRA was determined from our community partners, the project team’s knowledge of researchers and clinicians focused on aging research and cognitive care from local academic institutions, and from extensive work with individual caregivers participating in other research projects. Beginning with caregivers with some experience with research and trust in the project team was important to help ensure a balance of power and promote an open exchange of views among CRRA members. Working collaboratively, the multistakeholder nature of the CRRA was agreed upon in which more than half of its members were to represent community organizations and caregivers of persons with cognitive impairment, balanced with geriatric clinicians and gerontological researchers. An emphasis was placed on representation from the Black community, which was the focus of the federal grant supporting CRRA and a population disproportionately affected by cognitive disorders. All community members and caregivers were also offered a modest stipend for their time and service.

Initial CRRA meetings were designed to foster cohesion among members around a common charge, and to provide background on the need to increase diversity of older adults in research and information on CRRA logistics. The overall charge was to engage in honest and open discussion on the strengths and limitations of research and recruitment methods under review from the perspective of each stakeholder; advise on how study recruitment messaging, communications, and interactions can better reflect the interests, cultures, and concerns of intended participants; contribute in a manner that ensures the inclusion of all CRRA members; and to acknowledge the value of multiple backgrounds and perspectives.

In all meetings, we reinforced the importance and value of diverse perspectives with an emphasis on the value of community voices that are not systematically heard. We emphasized a core principle that research that is informed by diverse stakeholders, and notably those whom the research is intended to benefit, will be more effective and have more meaningful outcomes. Using first names was one important step in empowering all voices at the table, and universally accepted. Post-review meeting evaluations included questions on the extent to which a member felt empowered and comfortable speaking and results were presented at subsequent CRRA meetings as needed to emphasize the importance of balanced conversations and diverse perspectives.

Research Presenter Recruitment and Review Process

The first studies reviewed by the CRRA were, by design, those of CRRA research members to facilitate the group’s experience with the review process with known individuals. The process by which we recruited additional research presenters included outreach to established researchers regionally in the field of aging identified through clinical trial and other research records, communications with department chairs, presentations to research collaboratives, referrals from CRRA members, and presentations at national conferences. Additionally, the project director is a nationally known and respected geriatrician with a specialization in Alzheimer’s disease and related disorders who has generated interest especially from major pharmaceutical companies.

The process for each review was the same, though the length and number of CRRA review meetings varied based on a researcher’s goals. Researchers were asked to use lay language to provide an overview of their study in writing based on a standard list of questions, which was sent to CRRA members at least 1 week in advance of a scheduled review meeting. Researchers also had the option of providing draft study materials for CRRA review such as study flyers and recruitment tools. The materials provided by researchers summarized the study’s protocol and diversity goals.

During the 1- to 2-hour meetings, a researcher presented a study that was either being submitted for funding, part of a study that had not started active participant recruitment, or was in the early phases of recruitment. Researchers were invited to present their study at the beginning of a scheduled CRRA review meeting, which lasted from 1 to 2 hours. Ten minutes were typically reserved for these presentations plus an additional 5 minutes to respond to any questions from CRRA members. At that point, they were invited to leave and CRRA members proceeded with their review. This offered more authentic feedback given that the researchers were not present and responses were aggregated to maintain anonymity. After the meeting, feedback was consolidated by CRRA staff and sent to the CRRA membership to confirm and provide additional responses, an approach similar to the member-checking technique commonly used in qualitative research. All CRRA comments were included and there was no call for consensus or vote at CRRA meetings. The final written summary was provided to the presenting researcher, who also had the opportunity to talk with CRRA staff about the results. CRRA staff had follow-ups with researchers for any needed clarifications and after 1–2 months, to obtain updates on study progress and how CRRA recommendations were incorporated. This information was then shared with CRRA members at the next review meeting.

Data Collection

To date, the CRRA has reviewed 3 projects between January and December 2022 using an online meeting platform. Participation averaged between 15 and 18 members per review session. Representation from caregivers, followed by community organizations, was the most consistent. After each meeting, CRRA participants completed an optional feedback survey, which primarily consisted of Likert scale questions and several short open-ended questions on ways to improve the CRRA. To protect respondent identity in the survey, caregivers and community members were combined. Feedback from researchers and clinicians was also aggregated. Several months after presentations occurred, all presenters were asked to complete a survey that primarily consisted of Likert scale questions as well as short open-ended questions on strengths, limitations, and opportunities for the CRRA. Finally, a demographic survey was administered to all CRRA members in January 2023.

Analysis Plan

All data were analyzed in Stata 17 (StataCorp LLC, College Station, TX). This study was approved by the SUNY Upstate Institutional Review Board for the Protection of Human Subjects (#1988108-1).

Results

CRRA Member Characteristics

Among the 25 CRRA members, 36% (N = 9) are community members, 36% (N = 9) researchers, 16% (N = 4) caregivers, and 12% (N = 3) clinicians. The community members held multiple distinct roles, such as ministers/pastors, social workers, and outreach liaisons. The researchers and caregivers held a variety of roles within the study. The researchers served as college faculty, represented by 3 different private and public universities, as well as research support staff, which included study recruiters and clinical trial coordinators. Meanwhile, the caregivers functioned in roles such as directors, organizational cofounders, and support group facilitators. All the clinicians involved were clinician-scientists, all of whom were engaged in multifaceted studies involving older adults.

The mean age was 59.8 years (standard deviation: 12.7, range: 30–79). Most respondents self-identified as either non-Hispanic White (44%, N = 11) or non-Hispanic Black (44%, N = 11). The rest self-identified as Hispanic/Latino (8%, N = 2) or Asian (4%, N = 1). Majority of the members also self-identified as female (72%, N = 18) with the remainder self-identifying as male (28%, N = 20). In addition, most members reported having attained a graduate degree (80%, N = 20). A few others marked their highest education as an undergraduate degree (8%, N = 2) or high school graduate (8%, N = 2). While just 1 person stated their highest education as “some college” (4%, N = 1).

CRRA Member Feedback

Project 1

The first project was presented by a team of researchers seeking to recruit participants primarily from the Upstate New York region for an Alzheimer’s study. There were 5 completed surveys, in which 3 were from caregivers/community members and 2 were from researchers/clinicians (Table 1). Both researchers/clinicians reported they felt “very” prepared to participate in the CRRA meeting, whereas all caregivers/community members reported “somewhat” prepared based on the materials sent in advance. All respondents agreed they understood the information presented by the researchers, with a community member elaborating they were surprised at their understanding despite being nonclinical. Regarding their ability to share their views or comments during the meeting, most respondents reported “very able” (60%); however, 2 caregivers/community members reported “somewhat able” (40%). They elaborated these discussions were a learning curve, or that they felt intimidated because the discussion leaned toward the research or clinical members. All members also agreed they felt “prepared” (60%) or “somewhat prepared” (40%) to review and provide feedback on future studies. One of the caregivers/community members also expressed that getting more CRRA experience will allow them to ease their fears from intimidation.

Project 2

The second project was presented by a clinician-scientist seeking to recruit older adults from the Upstate New York region into a diabetes study. There were 10 completed surveys, with half from caregivers/community members and half from researchers/clinicians (Table 1). All researchers/clinicians reported they felt “very” prepared to participate in the CRRA meeting, whereas several caregivers/community members reported “somewhat” prepared, in which multiple members commented they appreciated the materials that were sent in advance. All respondents agreed they understood the information that was presented. In response to their ability to share their views or comments during the meeting, most respondents reported “very able” (80%); however, 2 caregivers/community members reported “somewhat able” (40%). One caregiver/community member commented that they were not able to express their opinions unless prompted by the moderator. However, multiple researchers/clinicians commented they actively scaled back their comments to allow the caregivers/community members to share their views more. All respondents also agreed they felt “prepared” (80%) or “somewhat prepared” (20%) to review and provide feedback on future studies.

Project 3

The third project was presented by a pharmaceutical company seeking guidance to recruit and retain diverse older adults nationally into an Alzheimer’s treatment clinical trial. This project was split into 4 meetings that centered on a specific theme: study overview, protocol and patient experience, community outreach, and caregiver experience. Only the last 3 meeting themes solicited feedback; therefore, surveys were not administered for the first meeting. Over time, from the first meeting until the last meeting, each evaluation item trended toward increasingly positive feedback (Table 2).

The first meeting was a presentation that provided context on Alzheimer’s and the mechanism for the proposed pharmaceutical drug to treat the disease. The second meeting solicited feedback after a presentation that described the protocol for the prescreen, main screen, and treatment period. Both the caregivers/community members and researchers/clinicians wrote they valued the graphics included in the presentation that visualized and detailed each step throughout the study. One caregiver/community member commented they appreciated how the pharmaceutical company genuinely appeared to respect and incorporate the feedback they received. The third meeting solicited feedback after a presentation on their proposed recruitment activities in community outreach events. Nearly all the open-ended comments in the feedback were added by researchers/clinicians, who expressed they appreciated the clear presentation slides and a list of specific questions sent in advance of the meeting, which allowed them enough time to prepare and provide more constructive feedback. The final meeting solicited feedback on the experience of the caregiver, which is generally necessary for studies in which the study participant has cognitive impairment. There were few responses for the feedback survey; however, 1 caregiver/community member wrote they also appreciated the presentation and questions were sent in advance to allow them to prepare for the meeting.

Presenter Feedback

Overall, each presenter had a very positive experience based on all evaluation criteria that covered topics on general satisfaction, recruitment strategy impact, study design impact, and future adoption (Table 3). When asked to describe changes in their recruitment strategy based on CRRA feedback, presenters noted they had revised their recruitment flyers and were developing a video to demonstrate study procedures, such as magnetic resonance imaging. Due to a multicentered trial, the pharmaceutical company also noted that differences in each community would necessitate a tailored recruitment approach for community engagement.

Regarding study design changes, 1 presenter marked “not applicable” because their procedures could not be modified due to existing grant funding and collaboration with another university. Another presenter mentioned they would collect additional race-based measures and provide information to local resources when participants are debriefed. The pharmaceutical company discussed they would now provide additional resources to the participant and caregiver to maximize study retention, develop a chat box to answer quick questions, create a calendar to track visits, and create a separate simplified informed consent form to be more comprehensible for a lay audience.

In response to questions on future adoption, all presenters marked they would very likely recommend the CRRA to colleagues, utilize the CRRA for another project, and incorporate CRRA services into a grant budget. One of the presenters clarified they were highly interested in allocating funds for the CRRA but added a caveat—CRRA may not be appropriate for multicentered studies due to differences in community partnerships at each site.

All presenters were also asked to comment on strengths, weaknesses, and opportunities for the CRRA (Table 4). The presenters highly valued the ability to directly engage and address the needs of the community instead of making assumptions about how the research would serve the community. Diverse backgrounds and experiences in the CRRA membership were also repeatedly discussed as a major strength, which enabled the presenters to better understand issues they were unfamiliar with. For example, one of the studies offered respite care to alleviate caregiver burden. However, the presenter did not realize that many community members distrust respite care services or did not find this benefit useful.

Several weaknesses were also noted by the presenters. Particularly from the initial meetings, presenters felt minimal research knowledge among the caregivers and community members was problematic, and the membership should include only those that have participated in research before. Two of the projects included recruitment at multiple sites, which the presenters suggested may be a weakness because each site has unique needs. Scheduling was also noted to be a weakness for a large group of 25 CRRA members and multiple presenters during several meetings.

Finally, opportunities to improve the CRRA were shared. All presenters commented that the services provided by the CRRA need to be continued, particularly through financial support. Several presenters also commented that the presentation format could be potentially adjusted in the future, such as allowing more breaks to answer questions and receive real-time feedback.

Discussion

This study discusses our development of a multisectoral board of community members, caregivers, clinicians, and researchers to increase the diversity of older adults in biomedical research. Our results indicate positive feedback from all stakeholders, with an increasingly positive trend as the meetings progressed throughout the year. Not surprisingly, researchers and clinician-scientists felt very prepared and more comfortable in offering comments during meetings. As evidenced from the first meeting, community members initially had discomfort in expressing their views and comments, but these fears from intimidation eased over time by the final meeting. From the start to lessen potential intimidation, CRRA members purposely used first names and not their academic or professional titles. In short, openness was cultivated to enhance cooperative and effective discourse from a broad array of stakeholders.

The efficacy of CBPR approaches should not be overlooked. A 10-year recent systematic review reported that more than 85% of examined studies employing CBPR methods claimed statistically positive outcomes in the rate of accrual of minoritized racial-ethnic communities for clinical trials (17). As research-community partnerships gradually spread in popularity, more is elucidated regarding research engagement and optimization of a CBPR approach for specific vulnerable populations, such as older adults—particularly in trust-building (18–20). Another recent systematic review also found that involvement of older adults in the research process provided several notable advantages, such as developing a deeper appreciation of older adult issues, making more inclusive decisions, and giving a platform to hear directly from those marginalized (21).

Previous studies involving a community advisory board with partnerships between community members and researchers were found to be a beneficial strategy to increase the diversity of older adults for Alzheimer’s biomedical studies (3,22–24). In contrast to prior approaches, our CRRA is distinct in that our membership encompasses more representation from diverse stakeholders and a formal structure that offers services to multiple biomedical studies upon request. Multiple presenters noted the inclusion of diverse community members and caregivers was a tremendous asset, as they could directly seek their guidance to enable their research to be more patient-centered. Inclusivity of community members in all phases of research is repeatedly emphasized as an imperative to increase engagement, foster community trust, and improve community health (25,26). To some researchers, the engagement of community partners at all stages is a vital driver of success in the CBPR model and, when excused, can lead to lackluster results (27,28).

There are opportunities to improve and expand on the CRRA. There were 25 active CRRA members. However, comments from caregivers and community members mentioned there were instances they felt it was difficult to contribute because there were at times multiple people talking at once. A presenter had also commented that a large group made scheduling difficult. Although the size of a community advisory board may vary depending on the research-related objectives and specific goals, some have reported 10–16 members as the ideal range (29). They also stated that any greater number of members has been reported as a greater challenge to facilitate, while any less may lead to low attendance of participants at some meetings. Second, a large duration of the initial meetings was focused on explaining basic research methods instead of providing feedback for the presented project. Caregivers and community members noted this was because they were unfamiliar with research procedures. Likewise, one of the presenters also suggested the lack of research experience among several members was a weakness. They also suggested that members should only be included if they have participated in research studies before or at least have a basic understanding of research methodology. Third, there was consistent feedback from all members that materials and proposed questions sent 1 week in advance were very beneficial. This allowed everyone to review the presentation, write down questions, and brainstorm initial feedback in preparation for each meeting. Therefore, this strategy was strongly recommended to continue in future iterations.

Much of the feedback from CRRA members has been brought back for discussion at scheduled review meetings. The timing of distributing materials to CRRA members was addressed early on. While there was an initial, intentional focus on building education on research methods in the initial CRRA meetings for community member and caregivers specifically, this was not continued. Similarly, when researchers/clinicians did dominate the first 2 CRRA meetings in particular, this was brought back to the CRRA with efforts to limit the length of researcher/clinician comments to encourage caregiver/community member voices, who were by then more familiar and comfortable in their roles. The size of CRRA meetings is also actively being discussed. More recent sessions have engaged an average of 15 members based on study topics. We are also expanding the scope of reviews to include research on adults generally and are testing approaches such as using topic-specific subgroups for CRRA reviews. Finally, we no longer prioritize experience with research in identifying new CRRA community members as this was a strategy to foster cohesion and a balance of power as the CRRA was first implemented.

For future studies, our CRRA should be considered for replication in other communities, beyond biomedical aging research. In addition, research is needed to increase diversity not only for race and ethnicity, but in other aspects, such as sex, urbanicity, and disability status. To ensure long-term sustainability of similar community advisory boards, an exploration of a fee-for-service model may be warranted. All presenters supported the continuation of our CRRA while 1 presenter even mentioned fees for this service should be budgeted in grant proposals. Consequently, a cost–benefit analysis may also be beneficial to explore commercial applications of our CRRA model. As a next step, an in-depth exploration through focus groups or interviews would also be informative to better understand member experiences across the different projects, such as motivations/tensions, limitations, and power dynamics they may have encountered. Collecting further subjective data may also elucidate how these experiences vary depending on whether the member identified as a caregiver/community member or researcher/clinician.

Our study has several limitations. First, most members were female-identifying, highly educated, and from a mid-sized urban community in Upstate New York. The approach we discuss in this paper may not be generalizable to other geographic settings and may not fully encompass the challenges or solutions pertinent to male, gender-diverse, or less-educated demographics. Second, our approach aims to increase diversity in biomedical aging research, though our current focus is primarily limited to increasing the representation of Black older adults given the racial-ethnic composition of our membership. Third, our findings reflect comments and changes that were made within 1 year due to grant restrictions that funded this endeavor, but future research will be needed to examine more long-term changes in participant diversity. Despite these limitations, this study is a noteworthy contribution to the field because to our knowledge, this is the first circumstance in which community members, caregivers, researchers, clinicians, and even a pharmaceutical company have gathered to discuss approaches to increase diversity in biomedical research.

Conclusion

At the federal level in the United States, multiple provisions have sought to significantly increase representation of underrepresented populations in biomedical research. For instance, the NIH Revitalization Act of 1993 mandated all federally funded research to include women and underrepresented groups as participants in clinical trials. And yet, after many years, gender and racial-ethnic disparities remain pervasive in clinical trials and publications (30,31). In 2022, the FDA also bolstered the federal commitment by drafting guidance for the pharmaceutical industry to increase underrepresented racial-ethnic enrollment in clinical trials (32).

The ethical and generalizability ramifications of this lapse in representation among clinical research participants are insidious, especially among vulnerable populations. Biomedical research in aging thus has a need for evidence-based inclusive-centered approaches. This study underscores 1 solution, as evidenced by our CRRA, a review board, where stakeholders unite to address research recruitment challenges. More multisectoral collaborations are still in urgent need to meaningfully further recruitment science, quality research, and patient-centered outcomes for all.

Funding

This work was supported by the National Institute on Aging (grant R24 AG065163, PI: Mary Sano), and this project was made possible through collaborations with Icahn School of Medicine at Mount Sinai and Recruitment Partners.

Conflict of Interest

None.

Author Contributions

R.W., S.E.M., N.H.S., C.A.D., K.R., and S.A.B. conceptualized and designed the study. R.W. and J.R.G. analyzed the data. All authors contributed to all sections of the manuscript and approved the final version of the article.

References