Abstract Details

Title Remote Enrollment Practices for Acute Stroke Clinical Trials During a Pandemic

Topic Cerebrovascular Disease and Interventional Neurology

Presentation(s) Cerebrovascular Disease and Interventional Neurology Posters (7:00 AM-5:00 PM)

Poster/Presentation
Number 025

Objective To study whether remote research enrollment practices incorporating telemedicine can alleviate clinical trial enrollment limitations during the COVID-19 pandemic.

Background Many clinical trials have suffered poor enrollment or 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, study interventions, and follow-up.

Design/Methods We retrospectively reviewed all enrollments in two Phase-III acute stroke clinical trials (NCT03735979, NCT03785678) at two tertiary stroke centers that routinely incorporate telemedicine into clinical research. Individual elements of trial enrollment were reviewed including: screening, consent, randomization, study intervention, and inpatient/outpatient follow-up. For each research phase, we compared the rate of successful completion and the number of study protocol deviations when conducted in-person versus via telemedicine using Fisher’s exact test.

Results Successful completion of individual clinical trial elements (in-person versus telemedicine) occurred during screening: 100% versus 100%; consent: 100% versus 100%; randomization: 100% versus NA; study intervention: 98% versus 100%; inpatient follow-up: 99% versus 100%; and outpatient follow-up: 94% versus 95%. Overall, clinical trial elements were completed successfully 473/481 (98%) times when in-person and 163/165 (99%) times via telemedicine (p=1.0). Study protocol deviations occurred (in-person versus telemedicine) during screening: 5% versus 4%; consent: 0% versus 0%; randomization: 0% versus NA; intervention: 12.5% versus 0%; inpatient follow-up: 4% versus 0%; and outpatient follow-up: 9.5% versus 6%. Overall, study deviations occurred when in-person 10/180 (5.6%) times and 2/77 (2.6%) times via telemedicine (p=0.26).

Conclusions Our study revealed no difference in successful completion of acute clinical trial research elements or study protocol deviations between telemedicine versus in-person. Incorporation of remote research practices, especially telemedicine, can support essential clinical research elements during and beyond the pandemic.

Authors/Disclosures
Abbey Staugaitis PRESENTER	Abbey Staugaitis has nothing to disclose.
	No disclosure on file
Denise Gaffney, RN (Kaiser Permanente Los Angeles Medical Center)	Ms. Gaffney has nothing to disclose.
Navdeep Sangha, MD (Kaiser Permanente)	Dr. Sangha has nothing to disclose.
Christopher Streib, MD (Department of Neurology)	Dr. Streib has nothing to disclose.

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Abstract Details