Researchers Are Revamping Processes to Gather Community Input
There is growing awareness of the importance of researchers engaging with the community when planning clinical trials.1 Some investigators are creating community advisory boards. “Involving a community advisory board during the design phase has many benefits,” says Barbara DeCausey, MPH, MBA, director of the human research protection program at Virginia Tech.
These boards help ensure the proposed research does not go against the values of the communities, adds credibility to the research, and increases participation. Currently, the development and implementation of clinical trials “are not patient- or community-centric,” according to Gaurav Dave, MD, DrPH, MPH, associate director of the University of North Carolina Center for Health Equity Research. Dave says adopting a patient-centered approach to designing study protocols is critical to the success of recruitment and retention of underrepresented populations in clinical trials. Dave says engaging communities during all phases of the clinical trial allows researchers to identify health priorities in the community, inform recruitment strategies and retention plans, and choose an appropriate study design. Additionally, this engagement can strengthen trust in research and foster civic engagement in trials.
“A patient-centric and community-engaged approach to research will also catalyze the prioritization of diversity, equity, and inclusion of underrepresented populations in clinical trials,” Dave asserts.
Emmelyn Kim, MA, MPH, MJ, CHRC, vice president of research compliance and privacy officer at the Feinstein Institutes for Medical Research in Manhasset, NY, says researchers must be connected to what is happening locally. Research staff must learn about the community’s top concerns. In turn, research staff can tell the community about the value of the research, such as contributing to science and public health.
“To make greater impacts to all of our communities, researchers need to get to know their community constituents in order to effectively engage,” Kim says.
To do that, researchers can tap into existing local patient or community advisory boards; diversity, inclusion, equity, and belonging committees; business employee resource groups; or other local organizations. “These are terrific forums to engage in discussions about their research ideas, as well as listen to community needs and input,” Kim says.
Input from community members can help researchers make the study more effective by providing participants with regular updates on the results and proactively translating research consent forms into preferred languages, instead of waiting for participants to ask. Investigators also could hire a staff representative of the community who can navigate cultural nuances and speak the preferred languages. “Researchers need to plan effectively, from a budgetary and human capital standpoint, to effectively engage with the population they are seeking to study,” Kim adds.
It is possible study participants might need remote options or help with transportation if in-person activities are necessary. “This will result in a more diverse participant pool, better data, and greater public benefit,” Kim says.
Researchers who conducted COVID-19 vaccine trials wanted to ensure participants reflected the U.S. population. They used multiple methods to engage Black, Indigenous, and People of Color (BIPOC) communities.2 As a result, 47% of participants in the trials for the Moderna mRNA vaccine were BIPOC.
“We were hoping that our enrollment numbers matched the U.S. demographics, and this goal was met and exceeded,” reports Michele Andrasik, PhD, senior staff scientist at Fred Hutchinson Cancer Center in Seattle.
Researchers concluded ongoing, intensive community engagement was needed to achieve diversity in clinical trials. “Resources and time must be allocated,” Andrasik urges. “A focus on relationships and involvement of community members early and often throughout the research is critical.”
The research team worked with clinical sites to identify people in the community who could offer input on study design. Community members made many helpful suggestions, including modifications to the informed consent form to ensure language was respectful and inclusive. Community members also suggested researchers acquire a fleet of mobile units to “take the research to the communities,” Andrasik says.
The researchers’ proven success in enrolling diverse populations are a roadmap for other researchers. The results “show concrete ways to effectively engage communities and build reputations of trustworthiness to enhance clinical trial enrollment and retention,” Andrasik offers.
Before starting a study, investigators should give some thought to the benefits for that community. “Particularly in minority communities, ‘gatekeepers’ and trusted sources should be engaged,” advises Traci Hayes, DrPh, MS, MBA, CHES, assistant professor of public health at the University of Southern Mississippi College of Nursing and Health Professions.
The point is for researchers to consider how the community will be better after the study is completed. “This should be explained in the IRB application, particularly if it’s positioned as a community-based participatory research project,” Hayes says.
When the community advisory group on which Hayes serves reviews study protocols, they ask these questions: Why is this important to this population? How will aiding the researchers’ project affect the participants’ daily lives? Is there compensation for the participants’ time and effort? Why this community or population, and not another?
The overarching question researchers should be asking, says Hayes, is: “Is this effort aligned with the priorities of the population of interest, or am I, the researcher, just simply conducting research for my own benefit?”
Learning about community members’ preferences also is important. Hayes and a colleague surveyed 74 African American women to assess the effectiveness of an approach to recruit and retain participants in a multiweek, community-based intervention.3 For women ages 51 to 69 years, a combination of radio, word of mouth, and church was more effective for recruitment. Younger women preferred texting. For researchers, those efforts pay off in more participation and better science. “In many cases, work that is inclusive will have greater value for an increased number of people,” Hayes says.
REFERENCES
1. Kelsey MD, Patrick-Lake B, Abdulai R, et al. Inclusion and diversity in clinical trials: Actionable steps to drive lasting change. Contemp Clin Trials 2022;116:106740.
2. Andrasik MP, Broder GB, Wallace SE, et al. Increasing Black, Indigenous and People of Color participation in clinical trials through community engagement and recruitment goal establishment. PLoS One 2021;16:e0258858.
3. Hayes T, Sharma M. Applying the integrated marketing communication approach to recruit and retain African American women. Health Promot Perspect 2021;11:460-466.
Input from community members can help researchers make the study more effective by providing participants with regular updates on the results and proactively translating research consent forms into preferred languages. Investigators also could hire a staff representative of the community who can navigate cultural nuances and speak the preferred languages.
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