Date of Award

Spring 5-18-2020

Degree Type

Dissertation

Degree Name

PhD Health Sciences

Department

Health and Medical Sciences

Advisor

Terrence Cahill, Ed.D.

Committee Member

Michelle D’Abundo, Ph.D.

Committee Member

Deborah DeLuca, JD

Keywords

minority recruitment, clinical trial recruitment, clinical trial diversity, ecological perspective for improving clinical trial diversity, pharmaceutical industry, clinical research professional perspective

Abstract

Inequitable participation in clinical trials continues to be a problem, and trial populations do not always reflect the demographics of the population that the investigational product will ultimately be treating. Because genetic differences between racial and ethnic groups affect the safety and efficacy of new treatments, it is important that standard of care decisions are made based on a representative population. The purpose of this study is 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 United States. This general qualitative study was both descriptive and exploratory in nature and utilized semi-structured, in-depth interviews for data collection. The socio-ecological model was utilized as the conceptual framework guiding this study (McLeroy, Bibeau, Stecker, & Glanz, 1988). The interview guide was designed to explore the perceptions, practices and experiences of 15 clinical research site professionals related to recruiting racially and ethnically diverse trial participants. Data analysis utilized a coding process in which data were coded inductively. Codes were classified according to the socio-ecological model. Following data analysis, 20 themes emerged from information pertaining to the actual implementation of minority recruitment practices. These 20 themes represent each level of the socio-ecological model and provide explanations for intrapersonal, interpersonal, organizational, community and policy components. A holistic view that facilitates a comprehensive understanding of effective minority recruitment practices is offered after considering the interaction of the components at all levels of the socio-ecological model. These multi-faceted findings reveal that an ecological perspective offers insight into improving access to clinical trials by focusing on environmental change initiatives, rather than individual change on a patient level. This study’s findings offer practical guidance for the implementation of change initiatives in minority recruitment practices at research sites. The results of this study demonstrate that environmental change can provide a premise for improving access to clinical trials among minority populations.

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