System-Level Transformations to Increase Patient Participation in Clinical Trials

Over the course of the COVID-19 pandemic, the Food and Drug Administration allowed cancer clinical trials to make modifications. As policymakers consider sustaining these modifications, understanding patient perspectives on impact is critical.

This cross-sectional study used survey data collected between August 2021 and September 2021 by the Translational Breast Cancer Research Consortium and December 2022 by Patient Advocate Foundation among female breast cancer survivors. Respondents reported how changes to location, telemedicine, convenience, and opting out of certain procedures would affect their willingness to participate in a trial. Respondents' county-level vulnerability was determined using five-digit Federal Information Processing Standard codes to link to the Social Vulnerability Index (SVI) overall theme (range, 0-1). According to the SVI, the most vulnerable counties are those in the upper 10% of the overall theme. Model-estimated odds ratios (ORs) and 95% CIs were estimated using multinomial logistic regression models to explore the association between county-level social vulnerability and willingness to participate.

Overall, 573 women were included, 12% lived in the most vulnerable counties, and 18% had previous trial participation. Over half (53%) reported that they would be very willing to participate in a trial that offered medication delivery to the home. When compared with all other counties, respondents in most vulnerable counties did not have increased willingness to participate in a trial using telemedicine (OR, 0.21 [95% CI, 0.07 to 0.63]). Results were similar for all other trial modifications, though not statistically significant.

Our sample of breast cancer survivors viewed trial modifications favorably. However, respondents in the most vulnerable counties were less likely to be influenced by these modifications. Research is needed to understand if additional modifications would influence participation of this vulnerable population.