A Snapshot of the Response from UK-based Clinical Trials of Investigational Medicinal Products to COVID-19.
A Snapshot of the Response from UK-based Clinical Trials of Investigational Medicinal Products to COVID-19.
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DOI：
10.7759/cureus.10613
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发表时间：
2020-09-23
期刊：
影响因子：
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通讯作者：
Henderson E
中科院分区：
文献类型：
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作者：
Neumann S;Henderson E
背景/目的2019冠状病毒病（COVID-19）给研究药物（CTIMPs）的非COVID相关临床试验带来了前所未有的挑战。这些挑战对于在高风险群体（如老年人）中进行的试验来说是相当大的。临床试验必须确保参与者的安全，同时也要考虑到试验干预对公共卫生的潜在和长期益处。在此，我们试图就英国老年人和神经病学相关的CTIMP对COVID-19大流行的反应和行为提供一个简要的视角。方法我们进行了一项横断面研究，调查CTIMP团队在英国进行广泛与老年人和神经病学相关的试验，以及申办者和临床试验单位（CTU），以了解对大流行的反应和准备。结果受疫情影响，半数以上试验暂停主动招募。暂停招募活动的主要原因是考虑到患者安全。有趣的是，大多数试验、申办者和CTU在2020年1月之前的风险评估中并未考虑大流行或流行病爆发。结论这些发现支持需要重新评估风险管理方法，即临床试验建立应急计划，预测但罕见的事件，以尽量减少中断招募和临床试验交付。
Background/Aims Coronavirus Disease 2019 (COVID-19) has presented an unprecedented challenge for non-COVID related clinical trials of investigational medicinal medicines (CTIMPs). These challenges are considerable for trials run in high -risk groups, such as older adults. Clinical trials must ensure the safety of their participants, whilst also considering the potential, and often long-term, benefits of the trial intervention to public health. Here we sought to provide a brief perspective on the response and conduct of CTIMPs relevant to older adults and neurology in the UK to the COVID-19 pandemic. Methods We performed a cross-sectional study, surveying CTIMP teams running trials broadly relevant to older adults and neurology in the UK, as well as sponsors and Clinical Trials Units (CTU), to understand the response and preparedness to the pandemic. Results Due to the pandemic, active recruitment has been suspended in more than half of the trials. The primary driver for the temporary halt of recruitment activity was considerations of patient safety. Interestingly, the majority of trials, sponsors and CTUs did not consider pandemic or epidemic outbreaks in their risk assessments before January 2020. Conclusion These findings support the need to re-evaluate the risk-management approach whereby clinical trials establish contingency plans for predicted but rare events to minimise the disruption to recruitment and clinical trial delivery.