Improving Representation in Clinical Trials and Research Building Research Equity for Women and Underrepresented Groups (2022) / Chapter Skim
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Appendix C: Improving Representativeness in Clinical Trials and Research: Facilitators to Recruitment and Retention of Underrepresented Groups
Appendix C: Improving Representativeness in Clinical Trials and Research: Facilitators to Recruitment and Retention of Underrepresented Groups
Pages 213-260
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Madison VA Geriatrics Research Education and Clinical Center, Middleton VA Hospital, Madison, Wisconsin (6) Center for Health Disparities Research, University of Wisconsin–Madison, Madison, Wisconsin *
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data as reported by the American Community Survey Demographic and Housing Estimates years 2010 to 2019. Study teams for those trials that met diversity criteria (50 percent or greater recruitment in at least one category)
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A call to action that involves providing resources, expanding the definition of stakeholders, integrating community-based stakeholders as equitable partners, and involving national funding organizations, academic institutions, and the scientific community is necessary to meaningfully advance work in this area. Keywords: recruitment, retention, minority, representation, clinical trial INTRODUCTION Clinical trials provide the most robust evidence to document the efficacy and safety of pharmacological and non-pharmacological interventions. Moreover, clinical trial evidence is often used to identify areas for future research as well as to guide funding priorities and allocation of resources.
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Importantly, increased representativeness in clinical trials assures the efficacy and safety of treatments in these diverse subgroups. The purpose of this study was to characterize current efforts on representativeness in clinical research and to systematically assess effective recruitment and retention strategies.
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To avoid penalizing research studies located in regions with low representation of target groups, studies were benchmarked to data from the American Community Survey Demographic and Housing Estimates years 2010 to 2019 collected by the U.S. Census Bureau using the region of recruitment.
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Extraction was completed in duplicate for each trial, and any discrepancies between reviewers were resolved through consensus. Data were extracted on clinical trial study design, study setting, study inclusion and exclusion criteria, and interventions.
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The goal of our rubric was to assess representativeness for each trial, taking into consideration the characteristics of the population available to those researchers in their communities. As such, to avoid penalizing research studies located in regions with low representation of target groups, studies were benchmarked to data from the American Community Survey Demographic and Housing Estimates years 2010 to 2019 (U.S.
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If yes, at what point in the process were they involved? " The Model Framework of Multilevel Factors Affecting Decision to Participate in Clinical Trial, which was proposed by Ford et al.
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A total of 1,279 clinical trials were randomly selected, stratified by disease category and geographic region. Careful review of abstracts and, when available, trial information on ClinicalTrials.gov, was performed applying inclusion and exclusion criteria to identify 162 eligible trials (three trials for each of the six CDC disease categories across the nine U.S.
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or state/national (multisite) data as reported by the American Community Survey Demographic and Housing Estimates years 2010 to 2019.
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navigating scientific, professional peer, and social expectations; (7) optimizing study team to ensure alignment with research goals; and (8)
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You're not respecting people. You're the ones that sit at these tables where we are not, how dare you all put out a drug that everyone can't use as if we're not dying from this disease." Frequent subthemes were the perception that clinical trials provided access to innovative treatments.
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Anticipating and Removing Barriers to Study Participation Included here are aspects of clinical trial participation that may influence accessibility to research for members of underrepresented communities. Highpriority subthemes focused on barriers to participation and removal of these barriers.
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If you have these populations that are vulnerable enough to have caregivers and other people who are already kind of with them maybe consider including them as part of the trial and obviously with patient consent, sort of incorporating it." Community advisory boards and other strategies for eliciting commiunity expertise were crucial to protocol development and study execution emerged in the context of this discussion. Finally, conceptualizing study participants as partners in research was an important component that required openness by the study team to learn from the participants' experiences.
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Study staff interact with potential study participants and are instrumental in recruitment and retention success. Diverse study teams were generally described as being helpful to recruitment given congruence between staff and potential participants, and this congruence was described in different ways depending upon the focus of the study (e.g., age, sex, race, ethnicity)
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We conducted 20 in-depth qualitative interviews with researchers from U.S.-based studies who succeeded at recruiting diverse samples. In addition, we examined reporting practices of cultural and demographic sample characteristics in 162 randomly selected U.S.-based clinical trials published between 2001 and 2021.
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This study extends beyond these three areas by capturing systems-level issues related to the characteristics and values of academic institutions, the need for increased funding support for these efforts, and recognition of the importance of representativeness in clinical trials as a social justice issue. In a recent systematic review, George et al.
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While 90 percent of the trials (n = 162) reported information on the sex/gender of their sample, none described the sexual orientation of their study participants.
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While thematic saturation was met for this specific cohort of researchers, we acknowledge that it is possible additional themes could emerge if time allowed for inclusion of an expanded cohort of more diverse study team members. CONCLUSIONS This study highlights several strategies to promote representativeness in clinical trials and provide practical and innovative recommendations for relevant stakeholders in the field: peers, journals, and funding agencies.
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Recruitment and retention of women for clinical leiomyoma trials. Contemporary clinical trials.
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Unequal burden of disease, unequal participation in clinical trials: solutions from African American and Latino community members. Health Soc Work.
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Under-representation of elderly and women in clinical trials. International Journal of Cardiology.
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try to make the sample representative of where I Female, Study am at the time, doing the work and where I am, there's Investigator a high percentage of LatinX. We need them in the work … to understand what's going on with them." "So women are somewhat easier to reach in that way Female, Study than men who are traditionally a little bit harder but Investigator not with this ethnic group.
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And, on the flip side, if you're a male enrolling into a clinical trial, you don't have to have any sort of birth control."
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So making sure those clinics were priorities for us and we did adjust a lot of our approach in working with the clinic." "So we partnered with community organizations, faith Female, Study based groups, leaders in those vulnerable communities Investigator that have traditionally been left out of research and just did a lot of outreach activities, both in person and in terms of health fairs and other community venues." "So we're using probability sampling in terms of Female, Study knowing the demographics from the last five years of Investigator the American community survey in these geographic locations, knowing the sex and age distribution and education distribution in these communities…So we're not doing all community engaged methods. We have to put some kind of boundaries around that so the validity of our data is still there and will not be questioned." continued
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And to me that is best practice." "I think we need to develop a process by which we have Male, Study relationships with people. It is through that ongoing Investigator feedback to the community or participants over time." "Community engagement is important for the Male, Study downstream care after clinical trials -- it is critically Investigator important and should not be ignored because I do think that, when we fail to do that, it is in the care process.
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I think Investigator that's really important if you want to have a relationship with the community, you don't just take. Whatever that community is, we try to teach you, we go to health fairs, we try to give something back." "Tokens of appreciation, we were constantly giving Female, Study feedback to the clinic about how many people we were Investigator recruiting, and then we gave feedback on our results and things we were finding and publishing." "That's who we're recruiting are staff members Female, Study and people interacting with participants from the Coordinator community.
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There's a lot of mistrust in Study trust with getting a letter from a random person, even though it has a Investigator community and university letterhead on it. You don't know anything about prior issues of the person or the research or if you're undocumented or don't distrust speak the language, if you've never been exposed to research, what the point is for research, there's many layers of trust that cannot be broached with an invitational letter and brochure." "I trust [her]
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I think the study team has to be present in many different ways." Bring "So really embedding our staff in the communities, completely Female, research to the doing all of the outreach and all of the clinical exams in the Study community community setting, making it as less clinical as possible, Investigator making every attempt to reach people where they live, work, pray, and play." "Right now, the series that we're going to start, we do them Female, in the area that we recruit from. So I also like to detach that Study from the institution because we have institutional events maybe Coordinator here because it's easy.
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That's just a traditional Study time for people to maybe gain a little bit of trust. And somebody Investigator would ask me a question that they didn't want to ask in front of everybody.
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I Female, think that certainly helps. But I think once you have established Study a relationship through your first baseline visit." Investigator Maintaining a "And so that's why we're hoping that the use of these Female, favorable study community outreach events that we did and the people who Study reputation with care about us and see a face to a name and you hear about it Investigator the community from other trusted leaders and champions in the community and that would give us an air of legitimacy in reaching out." "It starts conversations with friends, conversations when we're Female, not present, which is in the kitchens and the dining rooms.
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And so we built these relationships with our community partners for now more than a decade and have been and those relationships come with both give and take of information."
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Recruiting within that Investigator partnership is easy because you have trust build over many years." "I think that is the goal to get to full equity with the Female, community partner, writing grants and getting the money and Study sharing everything from the ground up to the study. I think Investigator we're still unequal with academic partners doing grant writing, getting funding, and working with community partners and giving them funding from the grant.
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. if you don't have Investigator those materials prepared and you don't anticipate the need to have those materials a priori, it sort of becomes a self fulfilling prophecy in that you're not going to accrue well or at all in those populations." Ensuring "We provided a helpline where people could call and just Female, Study study team leave a voicemail.
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. And how do you explain this Female, Study study materials to persons who don't have a background on just simple Coordinator and consent science?
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And they were like ‘You know, you're not going to get it there. You need to be looking here'." "Now in subsequent waves of recruitment, we've used a lot Female, Study more community engagement." Investigator Adapting study "I guess one of the models that I do a little bit differently than Female, Study protocols as some of my colleagues.
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I think data are far better than no data because, when we have no data, it's biased in systematic ways. When you have data from multiple sources, it's just a little bit more variable.
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. or someone who helps them Female, and family with their day-to day tasks, that was extremely important for Study involvement patients, and, perhaps, if they didn't have that in their life, it Coordinator in study helps would have been difficult for them to enroll and complete this participation study." "A lot of times patients rely on family member, or friends, or Female, other people in their lives to get them to appointments for this Study study." Coordinator Participants "And also revising things not just on our feedback but Female, as partners in their feedback.
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So it was way more of a free flow of information from the boots on the ground people to the decision maker for study design. And through that process they understand a lot of why we were doing things a certain way.
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. misinformed notion that Female, understanding of you have to be powered for an interaction term and Study recruitment and that's a real problem in review because it's not actually Investigator retention challenges what you want to know.
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But now they are specifically focusing on improving clinical trial diversity."
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So if somebody hasn't been following Study up with their folds for retention, they sort of appear on this Investigator slide in front of a team and it's like ‘Do better' and we'll move on with our lives." "I do like staff building events. Like I have people over at Female, my house.
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And I think those are important." "Although it's hard to achieve, it's best not to have a rotating Male, Study door study coordinators but to try to have the same study Investigator coordinator because I can tell you my patients developed relationships with me, my study coordinator, with my nurse, with these positions being fixed during the study period." "But I do think it depends on the level of experience of the Male, Study staff you have, right? If you're someone who is very, very Investigator new, it would be a colossal mistake to put them to do a study like this, because if we think about issues of trust, of science, you can break that trust in many different ways.
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I think we have to put our money where our mouth is, and I don't see that is happening. Especially because what is happening is that you're being held to task a lot more as a clinical trialist, you're held to task a lot more for hitting your recruitment targets.
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I think it would be much harder to accomplish Coordinator and increase diversity in clinical trials if both parties weren't doing everything they could to try and improve diversity." "I think everything comes back to money and time. You know, Female, I think the key is having time to make those connections, Study having time to reach these communities.
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So we're having grants Female, resources to to fund them and their staff and the work they do and the other Study community programs that they care about building and working on. So Investigator organizations having, working that into grants, it's really important." "I think that they actually have to provide financial incentives Female, for organizations, actually nursing staff, as well as the Study organizations to care about these issues.
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Yea, I would say throw money at Coordinator the diverse population." Creating "I think education, I mean recruiting more leaders and then Female, education education for those leaders, all in the spectrum in health care." Study resources and Investigator networks for study teams at federal and "This original trial we started recruiting back in XXXX. Female, institutional And, since then, I have really seen an increase in recruitment Study level strategies at national presentations we go to.
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