Clinical Trial Visits in the Age of COVID-19: Implementation of Research Participant Safety Measures.
Clinical Trial Visits in the Age of COVID-19: Implementation of Research Participant Safety Measures.
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DOI：
10.18203/2349-3259.ijct20211466
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发表时间：
2021-04
期刊：
影响因子：
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通讯作者：
Pierce JD
中科院分区：
文献类型：
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作者：
Krueger KJ;Rahman F;Shen Q;Hiebert JB;Pierce JD
COVID-19大流行正在对美国目前的临床试验进行方式产生重大影响。研究人员通过停止和推迟临床试验、缺乏个人防护设备（PPE）、关闭临床研究中心以及减少参与者招募，体验了COVID-19的影响。许多临床试验将有更多的缺失数据，因为受试者无法亲自参加访视，试验活动停止，或因COVID-19而中断时间敏感的研究数据收集。所有这些事件都会影响试验的数据质量。美国食品药品监督管理局（FDA）、美国疾病控制和预防中心（CDC）和美国国立卫生研究院（NIH）等政府机构已向开展临床试验的研究人员发出建议，以对抗COVID-19的传播并保持数据完整性。赞助临床试验的机构还提供了继续、修改或暂停研究的指南，这对确保参与者和研究团队的安全至关重要。主要建议包括实施远程医疗预约，佩戴防护口罩和面罩，如果暴露于COVID-19或旅行过，则应避免14天，如果可能，保持6英尺的距离。还建议研究者在现场访视之前和期间实施COVID-19筛查问卷。这包括参与者和研究人员在亲自收集数据之前完成体温检查和问卷筛选。本文将讨论进行临床试验的研究人员所遇到的挑战，并提供资源和例子，以协助研究人员在COVID-19大流行期间。
The COVID-19 pandemic is having a major impact on how current clinical trials are being conducted in the U.S. Researchers have experienced the effects of COVID-19 through the halting and delaying of clinical trials, the lack of personal protection equipment (PPE), the closing of clinical sites, and a decrease in participant recruitment. Many clinical trials will have more missing data because of a participant’s inability to attend in-person visits, discontinuation of trial activities, or interruption of time-sensitive study collection data due to COVID-19. All of these events affect the data quality of trials. Government agencies such as the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and National Institutes of Health (NIH) have issued recommendations for investigators conducting clinical trials to combat the spread of COVID-19 and to maintain data integrity. Institutions sponsoring clinical trials have also provided guidelines to continue, modify, or pause research studies that are essential to ensure participant and research team safety. Key recommendations include implementing telehealth appointments, wearing a protective mask and face shield, quarantining for 14 days if exposed to COVID-19 or having traveled, and, if possible, maintaining a 6-foot distance. It is also recommended that investigators implement COVID-19 screening questionnaires prior to and during on-site visits. This includes participants and research personnel completing a temperature check and questionnaire screen before in-person data collection. This article will discuss the challenges encountered by researchers conducting clinical trials and provide resources and examples to assist investigators during the COVID-19 pandemic.