Abstract P151: Remote Enrollment Practices for Acute Stroke Clinical Research Trials During a Pandemic

Abstract

Introduction: Many clinical trials have suffered poor enrollment or have been placed on hold due to the COVID-19 pandemic. Limitations on in-person interaction with patients, legally authorized representatives, coordinators, and physician investigators disrupt research processes including screening, consent, randomization, and study interventions. Remote enrollment practices incorporating telemedicine and electronic consent may address these enrollment limitations. Methods: We retrospectively reviewed clinical trial enrollments in two pivotal phase-III acute stroke trials (NCT03735979, NCT03785678) at two high-volume stroke centers that routinely use remote enrollments in clinical research. Individual elements of acute clinical stroke trial enrollment, including: screening, consent, randomization, and intervention were reviewed. For each research phase, we compared the rate of successful completion and research protocol violations for in-person vs remote research via Fisher’s exact test. Results: Forty patients were reviewed (median age 72 [IQR 63-84], 50% female, median NIHSS 13 [IQR 7.5-19.5]; 35 patient were enrolled and 5 were screened and consented, but found ineligible on qualifying imaging. All research phases were completed successfully with the exception of one in-person study intervention. Fisher’s exact test revealed no differences in protocol violations between research elements conducted remotely (predominantly via telemedicine) versus in-person (see Table). Conclusion: Our study revealed no difference in successful completion of acute clinical trial research elements when conducted remotely or in-person. Incorporation of remote research, especially telemedicine, may enable stroke clinical trial enrollments both during the COVID 19 pandemic and beyond.