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System-Level Transformations to Increase Patient Participation in Clinical Trials
Nicole E Caston1,2, Luqin Deng3, Courtney P Williams3
1Department of Medicine, Division of Hematology and Oncology, University of Alabama at Birmingham (UAB), Birmingham, AL.
JCO Oncology Practice
|March 13, 2025
Summary
Cancer clinical trial modifications were viewed favorably by breast cancer survivors. However, participants from socially vulnerable areas showed less willingness to engage with modified trial protocols, indicating a need for further research.
Area of Science:
- Oncology
- Public Health
- Health Services Research
Background:
- The COVID-19 pandemic prompted the Food and Drug Administration (FDA) to permit modifications to cancer clinical trials.
- Policymakers are evaluating the continuation of these trial modifications.
- Understanding patient perspectives on the impact of these changes is crucial for future policy decisions.
Purpose of the Study:
- To assess breast cancer survivors' perspectives on modifications made to cancer clinical trials during the COVID-19 pandemic.
- To investigate the association between county-level social vulnerability and willingness to participate in modified clinical trials.
Main Methods:
- A cross-sectional study surveyed 573 female breast cancer survivors.
- Data collected on willingness to participate based on trial modifications (location, telemedicine, convenience, opting out of procedures).
- County-level social vulnerability was assessed using the Social Vulnerability Index (SVI); multinomial logistic regression analyzed associations.
Main Results:
- Over half of participants (53%) were very willing to join trials with home medication delivery.
- Respondents in the most vulnerable counties (top 10% SVI) did not show increased willingness to participate in telemedicine trials (OR, 0.21 [95% CI, 0.07 to 0.63]).
- Similar non-significant trends were observed for other trial modifications in vulnerable populations.
Conclusions:
- Breast cancer survivors generally responded favorably to cancer clinical trial modifications.
- Individuals residing in highly socially vulnerable counties were less influenced by these modifications.
- Further research is necessary to identify modifications that could enhance trial participation among vulnerable patient populations.
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