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PP02-25: Socio-Ecological Elements Involved in Racial and Ethnic Minority Recruitment Practices for Industry-Sponsored Clinical Trials





Poster Presenter

      Becky Johnson

      • Associate Director, Global Patient & Site Solutions
      • IQVIA
        United States

Objectives

The purpose of the study was to understand the socio-ecological elements that are involved in the active implementation of racial and ethnic minority recruitment practices for biopharmaceutical-funded trials in the US.

Method

The research design is a descriptive, exploratory, general qualitative study utilizing telephone interviews.Data was collected Nov‘18-March‘19.Purposive sampling was used to recruit 15 clinical trial research staff members to provide their insights/experiences with recruiting minority participants.

Results

One overarching research question guides my study: What are the socio-ecological elements that are involved in the active implementation of racial and ethnic minority recruitment practices for biopharmaceutical-funded trials in the US? Five sub-questions were used, each addressing a different component of the socio-ecological model (SEM), the conceptual framework guiding this study. These 5 sub-questions cover intrapersonal, interpersonal, organizational, community and policy elements involved in active minority recruitment practices. Findings were organized using the SEM: Intrapersonal (respondent characteristics): • Interview respondents believe it is important to increase minority participation in trials • Respondents demonstrate a personal commitment to minority recruitment (i.e. opening their own research site specifically for that purpose) • Respondents receive satisfaction from their work, including having positive feelings from helping patients Interpersonal (respondent’s social network): • Respondents discussed a camaraderie amongst his/her co-workers • Respondents are not influenced by their colleagues to recruit minority participants Organizational (respondent’s research site): • Respondents’ research sites demonstrate a commitment to minority recruitment related to providing community education prior to introducing a trial opportunity • Respondents’ sites are just as committed to minority recruitment regardless of percentage of minority participants they recruit • Respondents’ research sites have a culture of inclusion • Respondents’ research sites’ missions guide recruitment efforts Community (interactions with patients): • Efforts are taken by respondent and/or his/her co-workers to develop trust • Respondents discussed taking action to encourage patients to take an active role in managing their health Policy (regulations set forth by trial funder): • Respondents discussed a lack of diversity emphasis by sponsors

Conclusion

This study contributes towards the scarcity of knowledge on strategies used in industry-sponsored trials for recruiting diverse participants, using the SEM as a conceptual framework. The SEM focuses on the interrelationships between individuals and their environments under the premise that behavior is affected by and affects the environmental system in which it is a part (McLeroy, Bibeau, Stecker, & Glanz, 1988). Implications • Satisfaction stemming from improving patient outcomes suggests a reciprocal relationship with the environment and has implications for future hiring decisions • Respondents not being influenced by colleagues to focus on diverse recruitment suggests an individual’s values may play a role in his/her active minority recruitment efforts - It may be prudent for sponsors, CROs or Federal Agencies to attempt to influence social norms via educational programs targeted towards sites for raising awareness of the critical need to improve access to clinical trials • Organizations demonstrate a commitment to minority recruitment regardless of investment barriers and ROI, suggesting a motivation beyond financial gain from meeting enrollment goals • Respondents discussed educating the community prior to introducing a study opportunity. Their efforts are likely fueled by the scarcity of nationwide attempts. Current efforts of industry stakeholders responsible for supporting sites with clinical trial recruitment (sponsors, CROs, etc.) largely focus on study-level recruitment. Efforts to educate stakeholders on this important differentiation for recruiting minority populations may serve beneficial as the respondents discussed how even they learned that traditional study recruitment approaches without first educating the community and building trust do not work for minority populations. Industry-wide, we need a paradigm shift in our recruitment approaches in order to improve access to clinical trials and achieve diverse representation.