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Review
. 2023 Feb:125:107064.
doi: 10.1016/j.cct.2022.107064. Epub 2022 Dec 23.

A community-informed recruitment plan template to increase recruitment of racial and ethnic groups historically excluded and underrepresented in clinical research

Affiliations
Review

A community-informed recruitment plan template to increase recruitment of racial and ethnic groups historically excluded and underrepresented in clinical research

Jennifer Cunningham-Erves et al. Contemp Clin Trials. 2023 Feb.

Abstract

Introduction: Engaging communities in research planning and implementation can enhance recruitment and retention (R&R) of racial and ethnic groups historically excluded and underrepresented in clinical research; however, most studies do not use community-informed approaches. This paper describes the formative research process used to design a Community-Informed Recruitment Plan Template for racial and ethnic groups historically excluded and underrepresented in clinical research.

Methods: Using an existing R&R template as a starting point, we iteratively developed and refined the community-informed template through a 3-phase process to achieve cultural-appropriateness. Phase 1 included a literature review, 34 community engagement (CE) studios to review recommendations, community advisory board (CAB) review, and survey data from minority recruitment experts. Phase 2 involved integration of content into existing R&R template. Phase 3 was a final review and revision using input of the CAB and researchers' panel. Survey data collected in Phase 1 were analyzed using descriptives (i.e., frequencies and percentages). Open-ended survey responses were analyzed using inductive, qualitative thematic analysis.

Results: The final 8-section template can help develop effective grant or proposal language where study R&R plans are requested. They include: 1) Recruitment Strategy; 2) A Stakeholder Communication Plan; 3) Evidence of Recruitment Feasibility; 4) Recruitment and Retention Team; 5) Recruitment and Retention Methods; 6) Recruitment and Retention Timeline; 7) Evaluation; and 8) Budget.

Conclusions: Incorporating multiple perspectives into this formative research process enhances the cultural appropriateness of this community-informed R&R template to help research teams achieve R&R goals for individuals historically excluded and underrepresented in clinical research.

Keywords: Clinical research; Minorities; Recruitment and retention plan; Research participation; Research recruitment; Research retention.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Figure 1:
Figure 1:
Community-Informed Recruitment and Retention Template Adaptation Process

References

    1. Clark LT, Watkins L, Piña IL, et al. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Curr Probl Cardiol May 2019;44(5):148–172. doi:10.1016/j.cpcardiol.2018.11.002 - DOI - PubMed
    1. Oh SS, Galanter J, Thakur N, et al. Diversity in Clinical and Biomedical Research: A Promise Yet to Be Fulfilled. PLoS Med Dec 2015;12(12):e1001918. doi:10.1371/journal.pmed.1001918 - DOI - PMC - PubMed
    1. Green AK, Trivedi N, Hsu JJ, Yu NL, Bach PB, Chimonas S. Despite The FDA’s Five-Year Plan, Black Patients Remain Inadequately Represented In Clinical Trials For Drugs. Health Aff (Millwood) Mar 2022;41(3):368–374. doi:10.1377/hlthaff.2021.01432 - DOI - PubMed
    1. Varma T, Wallach JD, Miller JE, et al. Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics. JAMA Netw Open Apr 1 2021;4(4):e217063. doi:10.1001/jamanetworkopen.2021.7063 - DOI - PMC - PubMed
    1. Reihl SJ, Patil N, Morshed RA, et al. A population study of clinical trial accrual for women and minorities in neuro-oncology following the NIH Revitalization Act. Neuro Oncol Aug 1 2022;24(8):1341–1349. doi:10.1093/neuonc/noac011 - DOI - PMC - PubMed

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