# Mixed-Methods Approach: Impact of Clinical Consenter Diversity on Clinical Trials Enrollment

## TL;DR

This study shows that the race and ethnicity of the person giving consent can influence whether people, especially Women-of-Color, decide to join clinical trials.

## Contribution

The study reveals that consenter diversity significantly impacts clinical trial enrollment decisions, particularly among Women-of-Color.

## Key findings

- Women-of-Color enrollers found consenter race and ethnicity important in their decision to join trials, unlike Northern European White women.
- No Northern European White enrollers considered consenter race important, while 11% of Women-of-Color enrollers did.
- The study highlights the need for larger research to improve clinical trial diversity and recruitment.

## Abstract

Historically, clinical trials have shown a significant lack of participant diversity. Ultimately, this lack of diversity in clinical trial recruitment widens the gap in the quality of healthcare treatment, delivery, and efficacy across populations. This study aims to explore the socio-cultural consenter qualities that may influence an individual’s decision to participate in clinical trials. Our results indicate that a consenter’s race and ethnicity were deemed as important among Women-of-Color (WOC), yet not important for Northern European White (NE White) women. Our findings provide evidence that additional studies are needed to better understand the factors that may influence a participant’s decision to enroll in a clinical trial study and ultimately enhance future recruitment for clinical trials.

Background: Clinical trials should benefit all people. Consequently, the National Cancer Institute expects cancer centers to accrue individuals to clinical trials in proportion to the cancer burden experienced by populations that live in their respective catchment areas; unfortunately, many cancer centers fail to meet this expectation. The person who gives consent for individuals in clinical trials frequently has significant contact with potential trial participants. We hypothesized that the race, ethnicity, and language of the consenter may have an important bearing on whether an individual chooses to participate in a clinical trial. Methods: We used mixed methods to investigate the impact of the socio-cultural background of the consenter on the decision of a potential research subject to participate in a clinical trial. Between 01/2018 and 02/2020, 205 women were approached in the sequential order they appeared in our breast clinic; of the 181 participants who agreed to complete the survey questionnaire, 94 (52%) were Northern European, non-Hispanic White (NE White), and 87 (48%) were Women-of-Color (WOC); this category includes participants who self-identified as Asian, Black, Hispanic/Latina, or Native American. Results: There were statistically significant differences according to the importance of the consenter’s characteristics in the decision to enroll or decline participation in the BCT. No NE White enroller (0%, n = 0) reported that consenter race was important versus 11% (n = 9) of WOC enrollers (p = 0.0009). Similarly, none of the NE White enrollers rated the consenter “looking like people in my community” as important versus 12% (n = 10) of the WOC enrollers (p = 0.0004). Conclusions: We find that consenter race and ethnicity are important for clinical trial diversity. Larger studies are needed to evaluate the generalizability of this finding.