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Published on: February 17, 2011
Mixed-Methods Approach: Impact of Clinical Consenter Diversity on Clinical Trials Enrollment
Angelica Sanchez1, Christina M Vidal1, Noé Rubén Chávez2
1City of Hope Comprehensive Cancer Center, Duarte, CA 91010, USA.
Cancers
|March 28, 2025
Summary
Consenter race and ethnicity significantly impact clinical trial diversity. Women of Color (WOC) participants were more likely to consider consenter race and community representation when deciding to enroll in breast cancer trials.
Area of Science:
- Clinical research ethics
- Health disparities
- Sociology of medicine
Background:
- Clinical trials aim to benefit all populations, but many cancer centers struggle with equitable participant accrual.
- The National Cancer Institute mandates proportional enrollment based on regional cancer burden.
- The characteristics of individuals obtaining consent may influence participant decisions.
Purpose of the Study:
- To investigate how the consenter's socio-cultural background affects a potential participant's decision to join a clinical trial.
- To examine the influence of consenter race, ethnicity, and language on trial enrollment.
Main Methods:
- A mixed-methods approach was employed to study consenter impact on trial participation.
- 205 women were approached in a breast clinic; 181 completed surveys.
- Participants were categorized as Northern European, non-Hispanic White (NE White) or Women-of-Color (WOC) including Asian, Black, Hispanic/Latina, or Native American.
Main Results:
- Significant differences emerged regarding the importance of consenter characteristics in the decision to enroll.
- 0% of NE White participants considered consenter race important, compared to 11% of WOC participants (p=0.0009).
- 12% of WOC participants found it important for the consenter to "look like people in my community," versus 0% of NE White participants (p=0.0004).
Conclusions:
- Consenter race and ethnicity are crucial factors influencing clinical trial diversity.
- Further research is necessary to confirm the generalizability of these findings across diverse populations.
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