Abstract
Introduction
The COVID-19 pandemic had an unprecedented impact on cardiovascular clinical research. The decision-making and state of study operations in cardiovascular trials 1-year after interruption has not been previously described.
Methods
In the spring of 2020, we created a pandemic impact task force to develop a landscape of use case scenarios from 17 device trials of peripheral artery disease (PAD) and coronary artery disease (CAD) interventions. In conjunction with publicly available (clinictrials.gov) study inclusion criteria, primary endpoints and study design, information was shared for this use-case landscape by trial leadership and data owners.
Results
A total of 17 actively enrolling trials (9 CAD and 8 PAD) volunteered to populate the use case landscape. All 17 were multicenter studies (12 in North America and 5 international). Fifteen studies were industry-sponsored, of which 13 were FDA approved IDEs, one was PCORI-sponsored and two were sponsored by the NIH. Enrollment targets ranged from 150 to 9000 pts. At the time of interruption, 5 trials were <20 % enrolled, 9 trials were 50–80 % enrolled and 3 trials were >80 % enrolled. At 1 year, the majority of studies were continuing to enroll in the context of more sporadic but ongoing pandemic activity.
Conclusions
At 1 year from the first surge interruptions, most trials had resumed enrollment. Trials most heavily interrupted were trials early in enrollment and those trials not able to pivot to virtual patient and site visits. Further work is needed to determine the overall impact on vascular intervention trials disrupted during the COVID-19 pandemic.
【저자키워드】 Food and Drug Administration, principal investigator, FDAFood and Drug Administration, CECclinical endpoints committee, clinical endpoints committee, DSMBdata safety monitoring board, data safety monitoring board, PAIINTERSPAndemic Impact on INTErventional device ReSearch, PAndemic Impact on INTErventional device ReSearch, PASSION CVPredictable and SuStainable Implementation of National Cardiovascular Registries, Predictable and SuStainable Implementation of National Cardiovascular Registries, PIprincipal investigator, NESTccNational Evaluation System for Health Technology Coordinating Center, National Evaluation System for Health Technology Coordinating Center, 【초록키워드】 pandemic, Trial, COVID-19 pandemic, Intervention, FDA, Coronary artery disease, International, Research, Patient, Study design, target, multicenter, information, disease, CAD, primary endpoint, criteria, Vascular, Enrollment, North America, study inclusion, Result, enrolled, described, develop, approved, majority, determine, NIH, ranged, 【제목키워드】 COVID-19, Trial, Intervention, Vascular,