Work

Promoting Diversity through an Understanding of Barriers and Drivers for Inclusive Clinical Trials

Year: 2025

Type: article

Abstract: IMPORTANCE: Racially and ethnically diverse, equitable representation among clinical trial participants is important for enhancing the drug development process and promoting equitable healthcare outcomes. OBJECTIVE: To understand the barriers and drivers for inclusive clinical trials, focusing on the attitudes, perceptions, experiences, and challenges faced by underrepresented populations. DESIGN: An online questionnaire was administered online from April to June 2023 and involved 12,017 respondents from 54 countries. This survey utilized a convenience sampling strategy. Statistical analysis was performed to compare responses among racial and ethnic groups. SETTING: The study was conducted globally. Survey respondents were recruited through various patient recruitment organizations, patient advocacy groups, and contract research organizations. RESPONDENTS: Adults 18 years or older who received an email or had online access were eligible to participate. Racial and ethnic composition included White (81%), Hispanic/Latino (15%), Black/African American (6%), Asian (6%), and other ethnicities. EXPOSURE(S): Respondents were asked about their perceptions, concerns and experiences related to clinical research access and participation. MAIN OUTCOME(S) AND MEASURE(S): Key outcomes included barriers to clinical research participation, factors influencing trust in pharmaceutical companies and past experiences. RESULTS: Barriers to clinical research participation varied among ethnic groups. Asian respondents cited concerns about time off work (22%) and time required to participate (19%) more frequently as compared to White respondents (7% and 7%, respectively; p < 0.05). Hispanics expressed higher concerns about time off work (15%) and receiving placebo (10%) as compared to Non-Hispanics (8% and 5%, respectively, p < 0.05). Black and Hispanic respondents placed higher importance on diversity in staff compared to White and non-Hispanic respondents (B: 32%; W: 12%; Hispanic: 22%; Non-Hispanic: 13% p < 0.05). Black, Asian, and Hispanic respondents reported higher levels of disruption in participation related to technology use (Black: 31%; Hispanic: 30%; Asian: 29%) and completing study requirements at home (Black: 32%; Hispanic: 30%; Asian: 26%) as compared to White (13%, 15%; p < 0.05%) and non-Hispanic respondents (14%, 17%; p < 0.05). CONCLUSIONS: The findings highlight the need to address barriers to diversity in clinical trials and improve trial experiences of underrepresented communities, facilitating design of more inclusive and patient-centered trials.

Source: Therapeutic Innovation & Regulatory Science

DOI: 10.1007/s43441-025-00751-9

Authors: Annick de Bruin, Jasmine Masullo, Shalome Sine, Kenneth Getz

Institutions: Center for Information and Study on Clinical Research Participation, Tufts University

Language: English

Topic: Ethics in Clinical Research

Subfield: Public Health, Environmental and Occupational Health

Field: Medicine

Domain: Health Sciences

SDGs: Reduced inequalities, Good health and well-being

Open Access status: hybrid

Estimated APC paid: $4,090