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.

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

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发表日期：

2025年2月26日

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

摘要

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.