Sathian Brijesh, Asim Mohammad, Banerjee Indrajit, Pizarro Ana Beatriz, Roy Bedanta, van Teijlingen Edwin R, do Nascimento Israel Júnior Borges, Alhamad Hanadi Khamis
Geriatrics and long term care Department, Rumailah Hospital, Hamad Medical Corporation, Doha, Qatar.
Centre for Midwifery, Maternal and Perinatal Health, Bournemouth University, Bournemouth, England, United Kingdom.
Nepal J Epidemiol. 2020 Sep 30;10(3):878-887. doi: 10.3126/nje.v10i3.31622. eCollection 2020 Sep.
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.
截至2020年9月21日，世界卫生组织报告全球范围内新型冠状病毒肺炎（COVID-19）确诊病例超过3118.6万例，其中死亡96.2343万例。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，对研发针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的疫苗以及治疗COVID-19的关注，正在扰乱全球许多即将开展和/或正在进行的针对其他疾病的临床试验。2020年3月18日，美国食品药品监督管理局（FDA）发布了一份关于在当前卫生紧急情况下开展临床试验的更新指南。诸如保持社交距离和隔离等潜在挑战，导致研究参与者无法参加面对面的预定研究访视和/或随访，试验人员也无法到位。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紧急关注。因此，我们对文献的系统评价旨在评估COVID-19大流行对临床试验和研究开展的影响。在PubMed、MEDLINE、Embase、谷歌学术和谷歌电子数据库中搜索用于综述的相关文章时，使用了关键词“COVID-19”和“临床试验”。主要发现包括：大多数正在进行的临床试验中受试者入组延迟和操作存在差距，这反过来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之外开展临床试验的大多数机构都经历了时间线延迟以及因这场大流行而完全停止运营，从而影响了临床研究结果。
