The effect of modifications to clinical trial activities implemented during the COVID-19 pandemic on willingness to participate in clinical trials: The TBCRC 057 survey.
Authors: Smith Karen L. , Mazza Gina L. , Mead-Harvey Carolyn , Shinn Eileen H. , Frank Elizabeth S. , Melisko Michelle E. , Eaton Cyd , Salamone Jeannine M. , Pollastro Teri , Spears Patricia , Wolff Antonio C. , Rocque Gabrielle Betty 
Published: September 2022

97

Background: In order to maintain safety, clinical trial activities have been modified during the COVID-19 pandemic. As part of the TBCRC 057 survey, we assessed how pandemic-related modifications to trial activities affect breast cancer patients’ willingness to participate in clinical trials. Methods: US residents with breast cancer were eligible to complete the online survey 8/6/21 – 9/30/21. Respondents rated whether each of 11 modifications to clinical trial activities would affect their decision to participate in a trial during or after the pandemic. Items evaluated modifications that involved changing the location of trial activities to closer to home, switching trial activities to telemedicine and making the trial schedule more flexible and convenient. Response options were “much less likely to participate”, “somewhat less likely to participate”, “would not affect my decision whether or not to participate”, “somewhat more likely to participate” and “much more likely to participate”. Current trial participants were asked to consider how modifications would affect their decision to participate in another trial. Results are reported descriptively. Results: Among 385 respondents, median age was 52 (range 25-85), 88.6% were non-Hispanic White, 52.5% had metastatic disease, 93% were receiving active treatment, 48.6% received care at an academic center and 9.6% were current trial participants. Changing location of trial activities was viewed favorably, with 70.2%, 64.6% and 54.1% of respondents indicating they would be much or somewhat more likely to participate if they could complete trial blood tests, x-ray tests or doctor visits closer to home, respectively. Similarly, the option to complete trial activities electronically was viewed favorably, with 59.6%, 58.6% and 60.9% of respondents indicating they would be much or somewhat more likely to participate if they could complete trial doctor visits, consent and questionnaires via telemedicine, respectively. With regard to modifications to make the trial schedule more flexible and convenient, respondent feedback was also favorable. 71.4%, 67.7% and 82.4% of respondents indicated that requiring study site visits no more than once per 3 weeks, widening windows for trial activities and offering home delivery of oral study medications, respectively, would make them much or somewhat more likely to participate. Finally, 30.4% and 51.7% indicated that the flexibility to opt-out of research-only blood tests and biopsies, respectively, would make them much or somewhat more likely to participate. Conclusions: Patients view modifications to trial activities implemented during the pandemic favorably. Trials should be flexible and the option to conduct study activities close to home or electronically when possible should be maintained during the pandemic and beyond.