Improving Representation in Clinical Trials and Research Building Research Equity for Women and Underrepresented Groups (2022) / Chapter Skim
Currently Skimming:
4 Barriers to Representation of Underrepresented and Excluded Populations in Clinical Research
4 Barriers to Representation of Underrepresented and Excluded Populations in Clinical Research
Pages 75-106
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 75... ...
INDIVIDUAL AND COMMUNITY FACTORS Individual and community factors are often cited as reasons for lack of inclusion of underrepresented and excluded populations in clinical trials. The evidence suggests, however, that many of these concerns misrepresent barriers to participation in research or are surmountable with effort from research teams, funders, and policy makers.
|
From page 76... ...
. When this report was written, the committee could not find any literature specific to frontier populations' participation in clinical trials and clinical research.
|
From page 77... ...
Although not as extensive, studies of American Indians echo those of Black and Latinx Americans. A study of American Indian college students found that, depending on the specifics of the trial, anywhere between 63 percent and 84 percent would probably or definitely agree to participate in a cancer clinical trial (Sprague et al., 2013)
|
From page 78... ...
, the legacy of both historical and contemporary abuses in medical research is an important factor driving the lack of engagement of underrepresented populations with both health care and research. This holds true across a range of underrepresented groups, including Asian American, Black American, Latinx American, and Mexican American (Adeyemi et al., 2009; Behringer-Massera et al., 2019; Bonevski et al., 2014; Braunstein et al., 2008; Buchbinder et al., 2004; Bussey-Jones et al., 2010; Byrd et al., 2011; Corbie-Smith et al., 2002; George et al., 2014; Hardie et al., 2011; Haynes-Maslow et al., 2014; Hoyo et al., 2003; Hughes et al., 2017; James et al., 2017; Lor and Bowers, 2018; Moreno-John et al., 2004; Murphy and Thompson, 2009; Murphy et al., 2009; Newman et al., 2006; Occa et al., 2018; Scharff et al., 2010; Smirnoff et al., 2018)
|
From page 79... ...
. In a clinical trial exploring barriers and motivators to participation in clinical trials among 67 Black Americans, focus group themes included the perception that research would benefit white participants or the research institution more so than any underrepresented individuals enrolling in the study (BeLue et al., 2006)
|
From page 80... ...
Persistent and systemic efforts to delegitimize, underemphasize, or ignore the link between historical and contemporary occurrences of scientific misconduct/abuse and the mistrust of underrepresented populations toward research will certainly only continue to worsen current disparities in participation. Moreover, an inability or unwillingness of the research community to acknowledge and make efforts to address the roots of distrust/mistrust in underrepresented communities would stymie any movement toward increasing the trustworthiness of researchers in the view of underrepresented populations.
|
From page 81... ...
. Health literacy of patients and potential participants has been cited as a contributor to low participation in research, and low health literacy and numeracy skills are independently associated with less interest in research participation (Kripalani et al., 2019; Protheroe et al., 2009)
|
From page 82... ...
. INDIVIDUAL RESEARCH STUDIES The factors and problems that lead to the limited enrollment of underrepresented and excluded populations in clinical trials and research begin with and follow the life cycle of a project.
|
From page 83... ...
. Better understanding of patient- and community-level concerns about research and their needs for participation in clinical trials can lead to more effective outreach tailored to specific individuals and populations and improved patient experience in clinical trials through less arduous screening, more responsiveness to inquiries from potential participants, and more attention to participants' needs (Forsythe et al., 2019; Smith et al., 2015)
|
From page 84... ...
. In one systematic review of clinical research studies, patient and community involvement in designing recruitment and retention strategies, developing patient-facing information, helping to identify potential participants, or providing feedback on poor recruitment rates was associated with higher odds of a patient enrolling in a clinical trial (Crocker et al., 2018)
|
From page 85... ...
Additional research has shown that hiring diverse staff and providing proper training for clinical staff are important facilitators for improved recruitment and retention of diverse clinical trials participants (Butler et al., 2013; Quinn et al., 2012)
|
From page 86... ...
non-adherent patients, physicians can humbly inquire and ask the patient to reveal the reasons behind their behaviors, from which the physician can learn the barriers and identify potential levers for change." Investigator Biases Despite a demonstrated willingness to participate in research, underrepresented populations are often not asked by researchers to participate in clinical studies (Adeyemi et al., 2009; Byrd et al., 2011; George et al., 2014; Katz et al., 2006; Murphy and Thompson, 2009; Webb et al., 2019)
|
From page 87... ...
Most clinical research takes place at or near large academic centers that are less frequently used by some underrepresented populations compared with community health settings. The greater the distance between home communities and where patients are required to present for initial involvement, study visits, or exit interviews, the less likely they are to participate (Coakley et al., 2012; Sprague et al., 2013; Unger et al., 2016)
|
From page 88... ...
. For instance, asthma researchers trying to assess differences in bronchodilator response found that potential participants from underrepresented groups were more likely to have inadequate responses to the methacholine challenge, one of the inclusion criteria; however, the methacholine challenge cut-point may have lacked sensitivity for underrepresented populations given previously reported differences in methacholine responsiveness among different racial/ethnic groups (Hardie et al., 2010)
|
From page 89... ...
These analyses illustrate how the structure of current inclusion and exclusion criteria, intentionally or not, reduces opportunities for underrepresented individuals to participate in research. Research Processes Researchers are often not trained or skilled in explaining research methodologies or the potential positive impacts of research outcomes in ways that actively engage ethnically underrepresented populations (Bonevski et al., 2014; Hughes et al., 2017)
|
From page 90... ...
Prioritizing speed, combined with a historically uninformed approach to minority recruitment, has led to a system in which research trials do not adequately prioritize enrollment of underrepresented populations. Health-Care Access and Strong Primary Care Closely related to socioeconomic status is access to health care.
|
From page 91... ...
. As described earlier in this chapter, several studies have also determined that the distance to health care and clinical research from patient home or home communities is also a problem, since most clinical research takes place at or near large academic centers that are less frequently used by underrepresented populations compared with community health settings.
|
From page 92... ...
Nevertheless, the traditional academic medical center structure creates substantial barriers to adequately consider diversity, equity, and inclusion in clinical trials and research. Sustainably and meaningfully engaging underrepresented and underserved populations often does not align with the traditional paradigm of promotion and tenure.
|
From page 93... ...
Community Health Centers Other types of health services organizations, including community health centers and rural health centers typically provide care to diverse population groups and represent an untapped resource for clinical trial and research recruitment. Federally qualified health centers (FQHCs)
|
From page 94... ...
beneficial projects. Education Educators integrate the community Ensures learner service aligns with Develops interprofessional competencies; develops trainees' and community health needs community needs in respectful and communication, collaboration, and engagement skills; assessments when developing valued ways; evaluation allows exposes learners directly to local sociocultural contributors interprofessional learning improvement to community-based to health; and produces stories useful for marketing and opportunities.
|
From page 95... ...
Community-Engagement Mission Opportunity Benefit to Community Benefit to Academic Research Organizations Learners across health professions Increases exposure and connection to Provides additional labor for teaching hospitals' directly contribute to local learners, increases awareness of local community-related administrative functions; provides community health needs assessments health-improvement activities, and research practicums focused on survey design, focus processes as data collectors or presents more opportunities to codesign group development and execution, data analysis, data analysts, or by presenting results to community health needs assessments- reporting, program development, etc.; offers educators community groups. related health interventions.
|
From page 96... ...
local initiatives; and advances scholarly output. Clinicians and care teams, through their electronic health records, have robust linkages to hospitals' community health-improvement efforts and make appropriate and timely referrals to community assets that can provide social support and resources for patients and their families.
|
From page 97... ...
This research activity, however, will require infrastructure and support for the community health centers. Nevertheless, the barriers to clinical trials and research recruitment at community health centers are multifactorial.
|
From page 98... ...
This network, funded by the Health Resources and Services Administration, consists of 18 federally funded community health centers, with four research nodes and one national data coordi nating center.a, b The goal of CHARN is to improve patient care at this network of federally funded health centers by developing and refining clinical data systems; creating infrastructure to better collect patient data across health centers; training health center personnel in research methods and protocols; improving translation of research findings into effective, patient-centered clinical practice; and foster ing collaboration among care teams and other CHARN health centers.b CHARN centers also work to develop proposals to obtain additional funding through the federal government to execute these objectives. CHARN was expanded in 2014 to include several new initiatives.
|
From page 99... ...
It is clear that eliminating the factors and problems that limit trial participation would improve the generalizability of results. Problems that prevent the inclusion of diverse populations in industryfunded clinical trials include patient out-of-pocket costs, which are often not covered in the informed consent process; industry pressures to gather data quickly; and the selection of easy-to-recruit samples being incentivized (Iltis, 2004)
|
From page 100... ...
IRBs are charged with ensuring that risks to human subjects are minimized through the use of sound scientific processes and their review focuses on the following key elements of research proposals: risks and benefits to human subjects, safety, protections of privacy, equitable selection of human subjects, and informed consent, with particular attention to coercion and undue influence. The latter element of IRB review can present barriers to enrolling excluded and underrepresented populations.
|
From page 101... ...
. Although IRBs certainly have a role to play in increasing the representation of excluded and underrepresented populations in clinical trials and clinical
|
From page 102... ...
Funders Research funders have several roles and responsibilities that can influence the diversity of clinical trials. Traditionally, funders' roles include prioritizing research topics, approaches, and methods; receiving and evaluating grant applications; selecting suitable proposals for funding; and evaluating the output of the research (Brantnell et al., 2015; Kessler Foundation, 2011)
|
From page 103... ...
For example, transportation to trial sites is often a deterrent to participation of underrepresented populations, and need for childcare can limit participation of caregivers, who are more likely to be female. Collaboration with community organizations to colocate services in community venues, such as faith institutions, or provide mobile services may increase the reach and effectiveness of the clinical trial recruitment and retention efforts.
|
From page 104... ...
In addition to clinical effectiveness outcomes, funders often examine the impact of their research using metrics such as publications and patents produced. Making the diversity of participants that are recruited and retained an explicit outcome to be evaluated and reported can be an important strategy for enhancing patient and community trust in the research process, increasing the applicability of the research findings to women, minority communities, and older adults, and influence payers' and providers' acceptance of the findings for groups who were not adequately represented in the research.
|
From page 105... ...
(Moher et al., 2010) and other standards, and mandatory trial registration, such as ClinicalTrials.gov, have standardized and raised the quality of research design, reporting, monitoring, and transparency for clinical trials.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.