Cancer clinical trial access during the COVID-19 pandemic

ABSTRACT

Introduction: Cancer clinical trial conduction during the COVID-19 pandemic required a rapid move to virtual engagement to support participant and research team safety. We were faced with the challenge of translating our approach from in-person to virtual engagement for recruitment, enrollment, and delivery of the study intervention. We present our strategies to conduct cancer clinical trials focused on cancer risk reduction during the COVID-19 pandemic. Subject Recruitment Our multimodal approach utilized online platforms and established approaches like posters, flyers, and collaborating with community health workers to recruit participants. Our virtual engagement strategies include direct outreach to potential participants via email, the electronic medical record (EMR), and social media. Contact via email and the EMR was guided by study-defined eligibility criteria. Social media outreach was through institutional Twitter, Facebook, and video channel accounts. Twitter posts and chats were employed. Enrollment e-consenting and remote consenting processes were instituted via REDCAP. Delivery of the Educational Risk Reduction Intervention We also conducted the intervention using the Zoom platform and through a recorded video of the educational risk reduction intervention, which is shared with the participant via REDCAP. Challenges As documented by others, the greatest challenge to virtual engagement is lack of internet access and lack of digital literacy. These factors have a greater impact on underserved populations, including the elderly, those with low socioeconomic status, those located farther from the cancer center, and racially/ethnically diverse populations. Conclusion: By translating study outreach and processes to virtual engagement, we were able to facilitate clinical trial access across diverse community subgroups and support subject participation in clinical trials during the COVID-19 pandemic.