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Advancing Representation in U.S. Clinical Trials: An Analysis of Intent to Participate, Participation Dynamics, Barriers, and Motivations
Shetty, Maureen Elizabeth
Shetty, Maureen Elizabeth
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Thesis/Dissertation
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2025-05
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Business Administration/Interdisciplinary
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https://doi.org/10.34944/9ynp-kc75
Abstract
Oncology clinical trials are essential for advancing medical treatments, yet persistent disparities in participant demographics undermined their representativeness and inclusivity. This dissertation addresses two critical questions: who participates in breast and skin cancer clinical trials in the United States, and what motivates or prevents individuals from participating. The research is organized into two studies that examine representation and participation dynamics, offering actionable insights for enhancing equity in clinical research.
Study 1 analyzed demographic data from clinical trials conducted between 2017 and 2024, focusing on representation by gender and ethnicity relative to disease incidence rates. Data from www.clinicaltrials.gov revealed significant disparities: males were underrepresented in breast cancer clinical trials, and ethnic minorities, including African Americans and Hispanics, did not participate in both breast and skin cancer trials at rates reflective of their disease incidence rates. These disparities raised ethical and scientific concerns, as they limited the generalizability of findings and perpetuated healthcare inequities.
Study 2 investigated the motivators and barriers influencing clinical trial participation through a mixed-methods survey of over 300 adults. Motivators included access to innovative treatments, including the potential for more effective and personalized therapies, altruistic contributions to scientific research, and trust in healthcare providers. Treatment efficacy, especially within the context of precision medicine, emerged as a driving motivation for participation, as individuals increasingly sought therapies tailored to their genetic makeup and specific health needs. Barriers such as mistrust in medical research, logistical challenges, fear of side effects, and financial concerns deterred participation. The study highlighted the critical need to raise awareness, build trust, and address these barriers through targeted and culturally sensitive recruitment strategies.
The findings emphasized that addressing both representation and participation barriers was crucial to improving the inclusivity and effectiveness of clinical trials. By ensuring diverse participation, clinical trials could better contribute to the development of treatments that were more effective and tailored to a broader range of patients, supporting the larger trend towards personalized and precision medicine. This research provided practical recommendations for policymakers, healthcare providers, and pharmaceutical companies to motivate broader participation and reduce barriers, ensuring that clinical trials better reflected the diversity of the populations they served.
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