Duke University School of Medicine, Durham, NC, United States of America; Duke Clinical Research Institute, Durham, NC, United States of America.
Columbia University Irving Medical Center, New York, United States of America.
Cardiovasc Revasc Med. 2022 Dec;45:67-73. doi: 10.1016/j.carrev.2022.07.018. Epub 2022 Jul 26.
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.
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.
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.
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.
COVID-19 大流行对心血管临床研究产生了前所未有的影响。中断后 1 年内心血管试验的决策和研究操作状态尚未有过描述。
2020 年春季，我们成立了一个大流行影响工作组，从 17 项外周动脉疾病 (PAD) 和冠状动脉疾病 (CAD) 干预装置试验中开发了使用案例场景的概览。结合公开可用的 (clinictrials.gov) 研究纳入标准、主要终点和研究设计，试验领导层和数据所有者共享了该使用案例场景的信息。
共有 17 项正在积极招募的试验 (9 项 CAD 和 8 项 PAD) 自愿参与了使用案例场景的填充。所有 17 项都是多中心研究（北美 12 项，国际 5 项）。15 项研究由工业界赞助，其中 13 项是 FDA 批准的 IDE，1 项是 PCORI 赞助的，2 项是由 NIH 赞助的。入组目标范围从 150 到 9000 名患者。在中断时，5 项试验的入组率<20%，9 项试验的入组率为 50-80%，3 项试验的入组率>80%。1 年后，大多数试验在疫情活动更为零星但仍在继续的情况下继续入组。
在首次激增中断后 1 年，大多数试验已经恢复入组。中断最严重的试验是入组早期的试验和那些无法转向虚拟患者和现场访问的试验。需要进一步研究以确定在 COVID-19 大流行中断期间对血管介入试验的整体影响。
