Research process development mitigates effect of COVID-19 on stroke trial enrollment

ABSTRACT

Introduction: With hundreds of thousands of clinical trial patients enrolled yearly, the COVID-19 pandemic caused a significant, unexpected disruption in clinical trials across the world. US data showed a 70% enrollment reduction in April and a 38% reduction in July 2020, compared to prepandemic rates. We implemented processes during the initial phase of the pandemic to minimize participant and staff viral exposure, develop remote procedures, and ease communication barriers, while still maintaining enrollment goals. Methods: Our stroke research team developed multiple processes to help mitigate pandemic effects on our enrollment. We developed watchlists for eligible and interested patients who could not be enrolled due to national and local restrictions. As research staff was unable to approach patients in person, phone and email scripts were developed to ensure information was disseminated in a consistent fashion. Remote and alternate consent methods were implemented. We tracked the evolving national and local guideline changes, and began re-opening trials on May 23, 2020. We implemented a rotating pool of coordinators, including a site-specific sanitation plan, once it was safe to be on campus in-person. In person meetings were moved to a virtual platform. Enrollment data across for 10 active subacute stroke studies, each active over the 3 years of, 2018-2020, was analyzed for the months from March to June, with 2020 individually compared to 2018 and 2019 via the Student T-Test. Results: Total enrollment during these 4 months were 15 participants in 2018, 11 in 2019, and 15 in 2020, with no statistical difference between the years. No study patients nor staff contracted symptoms of COVID-19. Conclusion: Enrollment shows no significant changes despite COVID-19. New processes allowedthe timely reopening of clinical trials, an overall maintenance of enrollment rates, including a non-significant increase in 2020 compared to previous years. Our telehealth and virtual communicationfocused processes prioritize the safety of patients and staff while ensuring quality control andappropriate enrollment numbers.