Background: Many acute stroke clinical trials (ASCTs) are underpowered, inconclusive, or terminated early. A pervasive challenge to ASCT recruitment is the physical separation of patients, their legally authorized representatives, research coordinators, and clinician investigators when trial-eligible patients present emergently. Remote research practices (RRPs) may aid time-critical ASCT enrollment and follow-up, however, their feasibility and effectiveness are understudied. Methods: We retrospectively reviewed ASCT enrollment (NCT03785678, NCT03735979, NCT02072681) at two institutions. Essential clinical trial elements (ECTEs) consisted of eligibility screening, informed consent, randomization, study intervention, and inpatient/outpatient follow-up assessments. When conventional in-person clinical research was not possible, ECTEs were attempted via RRPs utilizing either telemedicine evaluation or telephone communication. The primary outcome was the successful execution of accurate, complete ECTEs by research communication modality (in-person, telemedicine, or telephone). The secondary outcome was the protocol violation rate by modality. We utilized Fisher’s Exact Test for primary and secondary outcomes and descriptive statistics to report RRP utilization. Results: A total of 1600 individual ECTEs were attempted on 169 subjects. RRPs were utilized for 53.7% of ECTEs (19.1% telemedicine, 34.6% telephone). ECTEs were more likely to be completed successfully with telemedicine (100%) than in-person (98.5%) or telephone (92.2%), (p<0.01). Additionally, protocol deviations were less common with telemedicine (0.0%) than in-person (2.6%), or telephone (2.8) (p=0.04). Randomization (94.7%) and outpatient assessments (90.3%) were frequently completed via RRPs compared to eligibility screening (39.1%), informed consent (40.2%), supervision of study intervention (36.8%), and inpatient assessments (21.9%). Conclusion: RRPs were widely utilized. Telemedicine execution of ECTEs was associated with the highest rate of successful completion and lowest rate of protocol deviations. These findings, while retrospective and confounded by indication, suggest RRPs are effective and require confirmatory study.

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Background: <break> Many acute stroke clinical trials (ASCTs) are underpowered or terminated early due to poor recruitment. A pervasive challenge to ASCT recruitment is the physical separation of patients, their legally authorized representatives, research coordinators, and clinician investigators when trial-eligible patients are identified. Remote research practices (RRPs) can facilitate time-critical ASCT enrollment and follow-up assessments, however, the feasibility and effectiveness are unknown.<break><break> <break><break>Methods<break><break>This case-control study retrospectively reviewed ASCT enrollment at two institutions. When conventional in-person clinical research was not possible, completion of study specific essential clinical trial events (ECTEs) were attempted via RRPs utilizing telemedicine evaluation or telephone communication. The primary outcome was successful execution of ECTEs by modality: in-person, telemedicine evaluation, or telephone communication. The secondary outcome was protocol violation rate by modality. We utilized Fishers Exact Test for primary and secondary outcomes and descriptive statistics to report RRP utilization.<break><break> <break><break>Results<break> A total of 1603 individual ECTEs were attempted for 171 subjects. RRPs were utilized for 53.9% of ECTEs (19.3% telemedicine, 34.6% telephone communication). ECTEs were more likely to be completed successfully via telemedicine (100%) than in-person (98.2%) or telephone (92.3%), (p<0.01). Additionally, protocol deviations were less common with telemedicine (0.0%) than in-person (2.6%), or telephone (2.8%) (p=0.04). More than half (53.4%) of randomized ASCT enrollments were dependent upon RRPs. Randomization (94.7%) and outpatient assessments (84.6%) were more frequently completed via RRPs compared to eligibility screening (40.7%), informed consent (40.4%), supervision of study intervention (44.6%), and inpatient assessments (18.8%).<break><break><break> Conclusion:<break> Remote research practices were effective and doubled randomized ASCT enrollments in comparison to conventional research models that are restricted to in-person interaction alone.<break><break>Telemedicine was associated with the highest rate of successful ECTE execution and the lowest rate of protocol deviations. These findings may be confounded by indication and further definitive study is indicated.

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.