Mayer Craig S, Huser Vojtech
Lister Hill National Center for Biomedical Communication, National Library of Medicine, NIH, Bethesda, MD, USA.
PeerJ. 2020 Oct 23;8:e10261. doi: 10.7717/peerj.10261. eCollection 2020.
Clinical trial registries can provide important information about relevant studies for a given condition to other researchers and the public. We developed a computerized informatics based approach to provide an overview and analysis of COVID-19 studies registered on ClinicalTrials.gov registry. Using the perspective of analyzing active or completed COVID-19 studies, we identified 401 interventional clinical trials, 287 observational studies and 64 registries. We analyzed features of each study type separately such as location, design, interventions and update history. Our results show that the United States had the most COVID-19 interventional trials, France had the most COVID-19 observational studies and France and the United States tied for the most COVID-19 registries on ClinicalTrials.gov. The majority of studies in all three study types had a single study site. For update history "Study Status" is the most updated information and we found that studies located in Canada (2.70 updates per study) and the United States (1.76 updates per study) update their studies more often than studies in any other country. Using normalization and mapping techniques, we identified Hydroxychloroquine (92 studies) as the most common drug intervention, while convalescent plasma (20 studies) is the most common biological intervention. The primary purpose of most interventional trials is for treatment with 298 studies (74.3%). For COVID-19 registries we found the most common proposed follow-up time is 1 year (15 studies). Of specific importance and interest is COVID-19 vaccine trials, of which 12 were identified. Our informatics based approach allows for constant monitoring and updating as well as multiple applications to other conditions and interests.
临床试验注册库可为其他研究人员和公众提供有关特定疾病相关研究的重要信息。我们开发了一种基于计算机信息学的方法，以提供在ClinicalTrials.gov注册库上注册的COVID-19研究的概述和分析。从分析正在进行或已完成的COVID-19研究的角度出发，我们识别出401项干预性临床试验、287项观察性研究和64项注册研究。我们分别分析了每种研究类型的特征，如地点、设计、干预措施和更新历史。我们的结果表明，美国拥有最多的COVID-19干预性试验，法国拥有最多的COVID-19观察性研究，法国和美国在ClinicalTrials.gov上的COVID-19注册研究数量并列最多。所有这三种研究类型中的大多数研究都只有一个研究地点。对于更新历史，“研究状态”是最新信息，我们发现位于加拿大（每项研究2.70次更新）和美国（每项研究1.76次更新）的研究比其他任何国家的研究更新得更频繁。通过使用归一化和映射技术，我们确定羟氯喹（92项研究）是最常见的药物干预措施，而康复期血浆（20项研究）是最常见的生物干预措施。大多数干预性试验的主要目的是治疗，有298项研究（74.3%）。对于COVID-19注册研究，我们发现最常见的提议随访时间是1年（15项研究）。特别重要且令人感兴趣的是COVID-19疫苗试验，我们识别出了其中的12项。我们基于信息学的方法允许持续监测和更新，以及应用于其他疾病和兴趣的多种用途。
