The Landscape of Cardiovascular Clinical Trials in the United States Initiated Before and During COVID-19

ABSTRACT

The Coronavirus Disease 2019 (COVID-19) pandemic has taken an unprecedented toll on the American healthcare system and economy. While numerous COVID-19 clinical trials have been initiated in hopes of curtailing its impact, most pre-existing clinical trials have been forced to suspend or limit activity, which itself can have significant consequences. Missed or postponed trial-related assessments may hinder data quality, and heterogeneity in data collection both across the country and over time introduces bias. In addition, COVID-19 may lower specific event rates due to patients avoiding the healthcare system that could result in underpowered outcome analyses, or conversely, some endpoints (mortality) may be inflated.