Improving Representation in Clinical Trials and Research Building Research Equity for Women and Underrepresented Groups (2022) / Chapter Skim
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5 Facilitators of Successful Inclusion in Clinical Research
5 Facilitators of Successful Inclusion in Clinical Research
Pages 107-126
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From page 107... ...
To that end, this chapter provides an overview of evidence on sentiments, facilitators, beliefs, and attitudes from study investigators, staff, and participants for overcoming barriers to the inclusion of women and underrepresented minorities outlined in Chapter 4.1 It highlights key themes and facilitators that have demonstrated effectiveness to enhance recruitment and retention of diverse populations in clinical studies. In each section, the findings include reports from 20 qualitative interviews conducted in 2021 with research teams (investigators and staff)
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From page 108... ...
. Next, a systematic review was conducted to identify published clinical trials in these six therapeutic areas between 2001 and 2021 that successfully recruited diverse populations, defined as having at least 50 percent or higher enrollment of the county-level base rate, the state-level base rate, or the national-level base rate (for single-site studies, county-level data were used; for multisite studies, state-level data or national-level data were used, depending on whether sites were within the same state or dispersed across the United States)
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From page 109... ...
navigating scientific, professional peer, and social expectations; (7) optimizing the study team to ensure alignment with research goals; and (8)
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The development of trust requires a long-term commitment by principal investigators, study teams, and local institutions involved in the research. Building trust over time takes consistent engagement in the community beyond the confines of the study itself, developing meaningful relationships with study participants, and giving to the community without the expectation of anything in return (Kretzmann and McKnight, 1993)
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(2019) , study participants noted several strategies that clinical research staff could employ to overcome barriers and improve participation and retention in clinical trials, including "…rapport with participants; attentiveness and sensitivity to patients' concerns or needs; flexible scheduling to accommodate participants after hours and on weekends; post visit follow-up telephone calls to assess participants' well-being and address any concerns; and regular touch-base contacts with participants." Adopting a Flexible Approach to Recruitment and Data Collection Research teams from the successful studies recognized the importance of flexibility to enhance recruitment and retention of diverse groups.
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From page 112... ...
recognizes the need to make trial participation less burdensome to enhance recruitment, and supports the use of flexible approaches to reduce the frequency of study visits, to build in flexibility in visit windows, to consider electronic communication or digital health technology tools to replace site visits, and to consider the use of mobile staff to conduct study visits in study participants' homes. Building a Robust Network by Identifying All Relevant Stakeholders Research suggests that engaging in mapping to identify all the relevant stakeholders in a community can help study teams develop more equitable study designs and identify individuals and organizations that can help drive the recruitment and retention of diverse study participants (Larkey et al., 2009)
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From page 113... ...
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." Further, conceptualizing study participants as partners in research was highlighted as important and requiring openness and flexibility by the study team to learn from the study participants' experiences. Navigating Scientific, Professional Peer, and Societal Expectations Research teams described challenges related to scientific and societal expectations, which sometimes conflicted with maintaining scientific rigor.
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From page 114... ...
may be critical to enhancing participant diversity. Research teams expressed concern that the current emphasis on recruitment and retention of diverse study participants contrasts with consistent underfunding of disparities researchers despite the additional costs needed to conduct diverse enrollment in all research studies.
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One example is the American College of Cardiology's Clinical Trials Research: Upping Your Game program, which is designed to train the next generation of clinical trial team scientists by developing women and underrepresented populations in cardiology. This program includes three 2-day sessions that focus on clinical trials research; networking with other clinical trialists, investigators, industry leaders, and regulatory stakeholders; and developing a personal career action plan (ACC, 2022)
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, which provides support to institutions to develop training opportunities for selected indi viduals. These fellowships and traineeships undergo peer review of the research and training plan, and include stipulations for professional development and men toring by eligible mentors.
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FACILITATORS OF SUCCESSFUL INCLUSION IN CLINICAL RESEARCH 117 BOX 5-2 Promising Practices for Supporting a More Diverse and Equitable Medical Workforce A growing body of research literature and an increasing number of examples identify strategies and practices that institutions and organizations can adopt to diversify talent pools, mitigate biases in evaluation and promotion, and create and sustain a positive, inclusive organizational climate. Among those practices, organizations should consider adopting and adapting -- in concert with evaluation to understand the impact of these interventions on their communities and within their institutional context -- are the following: To Recruit a Diverse Applicant Pool: • Work continuously to identify promising candidates from underrepresented groups and expand the networks from which candidates are drawn.
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From page 118... ...
In addition to funding, research teams emphasized education of researchers and providing supports such as professional networks and institutional resources with expertise in these areas. Finally, material support for community organizations so that they can build infrastructure to enhance enrollment in clinical studies also emerged as an important long-term necessity to enhance inclusion.
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Community-based research takes place where people live, work, and play. Effective community-based research settings create a bridge between the community, scientific institutions, and researchers and build trusting partnerships that are essential for successful research participation.
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As noted above, academic institutions play a critical role in recruiting and retaining diverse faculty and investing in the future workforce. Institutions and their surrounding communities also have natural ties, but these ties have not always benefited community members.
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The Eugene Washington PCORI Engagement Awards Program provides fund ing for research support projects that encourage involvement of patients, caregiv ers, clinicians, and other health-care stakeholders as integral members of the patient-centered outcomes research/comparative clinical effectiveness research (CER) enterprise.
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From page 122... ...
The Grand Challenges program funded three major projects with distinct health foci, including precision health, environmental resiliency, and substance use disorders.2 While these efforts are currently under way, they have led to an expansion of federal funds. The Grand Challenge on substance use disorder, for example, has helped hundreds of Indiana teens involved in the criminal justice system get screened for substance use issues, and has now expanded to eight additional counties with the help of a recent grant from the National Institute on Drug Abuse.3 The Wisconsin Alzheimer's Institute, Regional Milwaukee Office, is another example of an institution investing in communities to address issues and build relationships with great success (see Box 5-4)
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Invest ment is not simply giving information to the community; the WAI Milwaukee program devotes substantial time and resources fostering relationships with the community. Building relationships and trust, while acknowledging the health needs of the community, are the foundation of the program's community engagement activities, and these are prioritized well above a focus on the scientific needs and research participation.
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• Participate in community outreach through educational events, health fairs, and other venues. • Develop lasting relationships with study participants through regular contact and updates on the study.
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• Elicit perspectives of frontline staff and potential participants to optimize study protocols and community engagement. • Identify elements of the protocol that could benefit caregivers and provide incentives to engaging caregivers.
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Be mindful of hierarchical approach with academic institution as lead and strive to create more equitable collaborations. • Allow for flexibility in use of funding to incentivize clinicians, administrators, and stakeholders providing research support.
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