Strategies addressing barriers to clinical trial enrollment of underrepresented populations: A systematic review

Heller, Caren; Balls-Berry, Joyce E.; Nery, Jill Dumbauld; Erwin, Patricia J.; Littleton, Dawn; Kim, Mimi; Kuo, Winston Patrick

doi:10.1016/j.cct.2014.08.004

Cited by 229 publications

(214 citation statements)

References 43 publications

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“…Having a positive presence in the community reduces community members' mistrustful attitudes and fear of being exploited in research studies. Again, colearning principles are a key to increasing cultural sensitivity of outreach plans and materials, increasing recruitment, and maximizing retention of minorities (Kelley, Belcourt-Dittloff, Belcourt, & Belcourt, 2013;Heller et al, 2014;Otado et al, 2015). A common mistake that researchers make is to seek grants and then find a minority community at the last moment to do their research (a lack of historical presence).…”

Section: Researcher Attributesmentioning

confidence: 99%

Community-Engaged Strategies to Increase Diversity of Participants in Health Education Research

Khubchandani

Balls-Berry

Price

et al. 2016

Health Promotion Practice

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Minorities have historically been underrepresented in health-related research. Several strategies have been recommended to increase the participation of minorities in health-related research. However, most of the recommendations and guidelines apply to research in clinical or laboratory contexts. One of the more prominent methods to enhance minority participation in health-related research that has recently come to the fore is the use of community-engaged strategies. The purpose of this article is to summarize community-engaged outreach efforts that can be translated into useable strategies for health education research teams seeking to diversify the pool of research participants. Also, we provide a succinct overview of the various components of a research endeavor that may influence minority participation in health-related research. Finally, we analyze how health education specialists and SOPHE (Society of Public Health Education) can play a leading role in helping enhance minority participation in health-related research.

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Section: Researcher Attributesmentioning

confidence: 99%

Community-Engaged Strategies to Increase Diversity of Participants in Health Education Research

Khubchandani

Balls-Berry

Price

et al. 2016

Health Promotion Practice

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“…Although it has been nearly 20 years since the NIH established guidelines for the inclusion of women and minorities in clinical research [5], current accrual rates into CTs are low among minority and other medically underserved populations, including African American (AA) and rural residents regardless of disease, type of trial, or sponsoring agency [1,[6][7][8][9][10][11][12]. The barriers to CT participation have been studied extensively, with these barriers primarily falling into two categories: patient-and physician-related barriers.…”

mentioning

confidence: 99%

Promoting clinical research to medically underserved communities: Current practices and perceptions about clinical trial recruiting strategies

Tanner

Kim

Friedman

et al. 2015

Contemporary Clinical Trials

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“…Analogous data from other studies are not available. One possibility for the seemingly large refusal rate may be the well-documented distrust of medical research and hesitancy to enroll in studies among minority communities [55]. …”

Section: Discussionmentioning

confidence: 99%

Design, methods, and baseline characteristics of the Kids' Health Insurance by Educating Lots of Parents (Kids' HELP) trial: A randomized, controlled trial of the effectiveness of parent mentors in insuring uninsured minority children11Clinical Trials.gov NCT01264718.

Flores¹,

Walker²,

Lin³

et al. 2015

Contemporary Clinical Trials

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Background & objectives Six million US children have no health insurance, and substantial racial/ethnic disparities exist. The design, methods, and baseline characteristics are described for Kids’ Health Insurance by Educating Lots of Parents (Kids’ HELP), the first randomized, clinical trial of the effectiveness of Parent Mentors (PMs) in insuring uninsured minority children. Methods & research design Latino and African-American children eligible for but not enrolled in Medicaid/CHIP were randomized to PMs, or a control group receiving traditional Medicaid/CHIP outreach. PMs are experienced parents with ≥ 1 Medicaid/CHIP-covered children. PMs received two days of training, and provide intervention families with information on Medicaid/CHIP eligibility, assistance with application submission, and help maintaining coverage. Primary outcomes include obtaining health insurance, time interval to obtain coverage, and parental satisfaction. A blinded assessor contacts subjects monthly for one year to monitor outcomes. Results Of 49,361 candidates screened, 329 fulfilled eligibility criteria and were randomized. The mean age is seven years for children and 32 years for caregivers; 2/3 are Latino, 1/3 are African-American, and the mean annual family income is $21,857. Half of caregivers were unaware that their uninsured child is Medicaid/CHIP eligible, and 95% of uninsured children had prior insurance. Fifteen PMs completed two-day training sessions. All PMs are female and minority, 60% are unemployed, and the mean annual family income is $20,913. Post-PM-training, overall knowledge/skills test scores significantly increased, and 100% reported being very satisfied/satisfied with the training. Conclusions Kids’ HELP successfully reached target populations, met participant enrollment goals, and recruited and trained PMs.

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Strategies addressing barriers to clinical trial enrollment of underrepresented populations: A systematic review

Abstract: Multiple and flexible strategies targeting providers and participants at provider sites and within communities might be needed to enroll underrepresented populations into clinical trials.

Cited by 229 publications

References 43 publications

Community-Engaged Strategies to Increase Diversity of Participants in Health Education Research

Community-Engaged Strategies to Increase Diversity of Participants in Health Education Research

Promoting clinical research to medically underserved communities: Current practices and perceptions about clinical trial recruiting strategies

Design, methods, and baseline characteristics of the Kids' Health Insurance by Educating Lots of Parents (Kids' HELP) trial: A randomized, controlled trial of the effectiveness of parent mentors in insuring uninsured minority children11Clinical Trials.gov NCT01264718.

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