Impact of COVID-19 on clinical trials and clinical research: A systematic review.
Impact of COVID-19 on clinical trials and clinical research: A systematic review.
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DOI：
10.3126/nje.v10i3.31622
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发表时间：
2020-09
影响因子：
3.9
通讯作者：
Alhamad HK
中科院分区：
文献类型：
--
作者：
Sathian B;Asim M;Banerjee I;Pizarro AB;Roy B;van Teijlingen ER;do Nascimento IJB;Alhamad HK
背景资料：截至2020年9月21日，世界卫生组织已报告全球超过31，186，000例冠状病毒病（COVID-19）确诊病例，其中962，343例死亡。当前的COVID-19大流行正在影响世界大部分地区的临床研究活动。事实上，专注于开发SARS-CoV-2疫苗和COVID-19治疗，扰乱了地球仪各地许多即将进行和/或正在进行的其他疾病临床试验。2020年3月18日，美国食品药品监督管理局（FDA）发布了在当前卫生紧急情况下开展临床试验的更新指南。潜在的挑战，如社交距离和隔离，导致研究受试者和试验人员无法进行面对面的计划研究访视和/或随访。由于COVID-19的突然爆发和广泛影响，其对临床试验和研究管理的影响需要迫切关注。因此，我们对文献进行系统性综述，旨在评估COVID-19大流行对临床试验和研究的影响。在PubMed、MEDLINE、Embase、Google scholar和Google电子数据库中检索相关综述文章，包括关键词“COVID-19”和“临床试验”。主要发现包括：在大多数正在进行的临床试验中，受试者入组延迟和操作缺口，这反过来又对试验计划和数据完整性产生负面影响。在全球范围内，除COVID-19外，大多数进行临床试验的研究中心正在经历时间表的延迟和完全停止运营，从而影响临床研究结果。
Background: The World Health Organization has reported more than 31,186,000 confirmed cases of coronavirus disease-19 (COVID-19), including 962,343 deaths, worldwide as on September 21, 2020. The current COVID-19 pandemic is affecting clinical research activities in most parts of the world. The focus on developing a vaccine for SARS-CoV-2 and the treatment of COVID-19 is, in fact, disrupting many upcoming and/or ongoing clinical trials on other diseases around the globe. On March 18, 2020, the United States Food and Drug Administration (FDA) issued an updated guideline for the conduct of clinical trials during the current health emergency situation. The potential challenges, such as social distancing and quarantines, result in study participants’ inaccessibility and trial personnel for in-person scheduled study visits and/or follow-up. Due to the sudden onset and wide-spread impact of COVID-19, its influence on the management of clinical trials and research necessitates urgent attention. Therefore, our systematic review of the literature aims to assess the impact of the COVID-19 pandemic on the conduction of clinical trials and research. The search for the relevant articles for review included the keywords “COVID-19” AND “clinical trial” in PubMed, MEDLINE, Embase, Google scholar and Google electronic databases. Key findings include: delaying subject enrollment and operational gaps in most ongoing clinical trials, which in turn has a negative impact on trial programmes and data integrity. Globally, most sites conducting clinical trials other than COVID-19 are experiencing a delay in timelines and a complete halt of operations in lieu of this pandemic, thus affecting clinical research outcomes.
影响因子：
4
作者：
Waterhouse, David M.;Harvey, R. Donald;Schilsky, Richard L.
通讯作者：
Schilsky, Richard L.
影响因子：
4.7
作者：
Smith, Anthony C.;Thomas, Emma;Caffery, Liam J.
通讯作者：
Caffery, Liam J.
影响因子：
4.7
作者：
Holtz, Bree E.
通讯作者：
Holtz, Bree E.