Increased Utilization of Virtual Visits and Electronic Approaches in Clinical Research During the COVID-19 Pandemic and Thereafter

Abstract Objectives To assess the impact of the COVID-19 pandemic on clinical research and the use of electronic approaches to mitigate this impact. Methods We compared the utilization of electronic consenting, remote visits, and remote monitoring by study monitors in all research studies conducted at Mayo Clinic sites (Arizona, Florida, and Minnesota) before and during the COVID-19 pandemic (ie, between May 1st 2019 and December 31st 2020). Participants are consented through a participant tracking system linked to the electronic health record. Results Between May 2019 and December 2020, there were 130,800 new consents across every modality (electronic and paper) to participate in a non-trial (107,176 [82%]) or a clinical trial (23,624 [18%]). New consents declined from 5,741 in February 2020 to 913 in April 2020 but increased to 11,864 in November 2020. The mean (SD) proportion of electronic consent increased from 22 (2)% before to 45 (20)% during the pandemic (P=.001). Mean (SD) remote electronic consenting increased from 0.3 (0.5)% to 29 (21)% (P Conclusions After a sharp early decline, the enrollment of new participants and ongoing study visits recovered during the COVID-19 pandemic. This recovery was accompanied by the increased utilization of electronic tools.