Date of Award

Spring 5-3-2024

Degree Type

Dissertation

Degree Name

Doctor of Business Administration (DBA)

Department

Business

First Advisor

Dr. Satish Nargundkar

Second Advisor

Dr. Aaron Baird

Third Advisor

Dr. Subhashish Samaddar

Abstract

Background: Approximately 40% of the population in the USA is comprised of minority racial and ethnic groups. However, despite this demographic representation, a study by Gray et al., (2022) found that out of the 53 novel drugs approved in 2020, 75% of the 32,000 participants were white. A study done by Woods-Burnham, et. al., (2021), found that enhancing racial and minority enrollment in clinical trials holds significant promise for improving survival outcomes within these communities. By prioritizing and dedicating resources to inclusive clinical trials, we can ensure greater access to state-of-the-art therapies for minority populations at high risk.

Patients afflicted by rare diseases often experience cognitive or physical limitations that hinder their ability to move and function, posing obstacles to their involvement in clinical trials. This challenge is exacerbated by factors such as geographical dispersion, misdiagnosis, and the low socioeconomic status prevalent among many minority groups. This research aims to address the problem of the lack of diversity in all clinical trials, the effect of health equity on diversity, and access to clinical trials. It also aims to bring more awareness to the plight of the rare disease population, and how patient-centricity may improve the outcome.

Method: A 3-stage study was done utilizing 3 different groups of participants. The first stage (Group A) was a focus group in which a ninety-minute Zoom video discussion was conducted with a total of 19 participants with no direct ties to rare diseases. Individual one-hour interviews were conducted in the second stage of the study (Group B) with 10 participants other than those in Group A to obtain a deeper level of understanding of the diseases, experiences, and feelings of participants who are directly impacted by the disease to gain insights into their expectations and concerns with clinical trials as they relate to increasing diversity and patient-centricity. Finally, the third stage (Group C) was a survey group open to all ethnic groups. A total of 305 participants were enrolled. The purpose of this group was to support the findings of the interview groups and confirm or add to the information available in the literature.

Contributions: This study adds to the body of knowledge by providing actionable insights into the combined effects of both diversity and patient-centricity on the conduct of clinical trials and identifying strategic points at which the voice of the patient can be integrated into the drug development process.

DOI

https://doi.org/10.57709/36945315

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