TITLE:
Transformational Strategies to Improve the Clinical Trial and Drug Development Process
AUTHORS:
Allison Bowen, Satish Nargundkar
KEYWORDS:
Diversity, Health Equity, Clinical Trials, Drug Development, Clinical Trial Access
JOURNAL NAME:
Open Journal of Safety Science and Technology,
Vol.15 No.2,
June
6,
2025
ABSTRACT: Background: Clinical trial designs have historically been biased towards the Caucasian population, with limited representation of minorities due to factors such as financial barriers, inequity, and accessibility. This lack of diversity has resulted in the development of drugs that may not be effective or safe for underrepresented populations, thereby posing risks to minority health. This research aims to transform the clinical trial process by identifying innovative strategies to increase diversity, ensuring that clinical trials more accurately reflect the natural epidemiology of diseases, and ultimately driving improved drug development outcomes for all populations. Method: A three-stage study was conducted with distinct participant groups. Stage 1 (Group A) involved a 90-minute Zoom focus group with 19 biopharmaceutical professionals. Stage 2 (Group B) consisted of one-hour individual interviews with 10 patients or healthcare providers to explore their experiences and views on trial diversity. Stage 3 (Group C) used a survey of 305 diverse participants to validate and expand the findings. Results: Barriers to diversity in clinical trials that were identified include a lack of trust, limited access to trial facilities, socioeconomic challenges, ineffective recruitment strategies, and a shortage of culturally competent healthcare providers. Proposed solutions include transforming the trial process through regional trial hubs to enhance access, implementing culturally tailored recruitment strategies, and using telemedicine to reduce participant burden. Additionally, updating the DIVERSE Trials Act, implementing federal protections for clinical trial participants—similar to those provided for jury duty—and promoting transparency through community engagement can help rebuild trust and improve diversity in trial participation. Conclusion: This study demonstrates the significant impact of a lack of diversity in clinical trials on both drug development and health equity, emphasizing how disparities in patient access hinder the inclusivity of clinical research. By exploring how the clinical trial process can be transformed to increase diversity and access, the study offers practical, actionable solutions, including targeted recruitment strategies, regional trial hubs, and culturally tailored outreach. Additionally, it illustrates how diversity in the patient population enhances the drug development process, ensuring clinical trials better reflect the natural epidemiology of the disease and improve the safety and efficacy of treatments. Through its interdisciplinary approach, grounded in complementary theories, this study provides valuable insights and significantly contributes to the literature, offering a roadmap for improving inclusivity in clinical trials and advancing health equity.