Institute of Medical Virology, University of Zurich, Zurich, Switzerland.
Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, Zurich, Switzerland.
BMC Infect Dis. 2022 Jul 28;22(1):654. doi: 10.1186/s12879-022-07621-x.
The rapid course of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic calls for fast implementation of clinical trials to assess the effects of new treatment and prophylactic interventions. Building trial platforms embedded in existing data infrastructures is an ideal way to address such questions within well-defined subpopulations.
We developed a trial platform building on the infrastructure of two established national cohort studies: the Swiss human immunodeficiency virus (HIV) Cohort Study (SHCS) and Swiss Transplant Cohort Study (STCS). In a pilot trial, termed Corona VaccinE tRiAL pLatform (COVERALL), we assessed the vaccine efficacy of the first two licensed SARS-CoV-2 vaccines in Switzerland and the functionality of the trial platform.
Using Research Electronic Data Capture (REDCap), we developed a trial platform integrating the infrastructure of the SHCS and STCS. An algorithm identifying eligible patients, as well as baseline data transfer ensured a fast inclusion procedure for eligible patients. We implemented convenient re-directions between the different data entry systems to ensure intuitive data entry for the participating study personnel. The trial platform, including a randomization algorithm ensuring balance among different subgroups, was continuously adapted to changing guidelines concerning vaccination policies. We were able to randomize and vaccinate the first trial participant the same day we received ethics approval. Time to enroll and randomize our target sample size of 380 patients was 22 days.
Taking the best of each system, we were able to flag eligible patients, transfer patient information automatically, randomize and enroll the patients in an easy workflow, decreasing the administrative burden usually associated with a trial of this size.
严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）大流行的快速发展需要迅速实施临床试验，以评估新治疗和预防干预措施的效果。在现有数据基础设施中构建嵌入试验平台是在明确的亚人群中解决此类问题的理想方法。
我们在两个已建立的全国队列研究的基础设施上开发了一个试验平台：瑞士人类免疫缺陷病毒（HIV）队列研究（SHCS）和瑞士移植队列研究（STCS）。在一项名为 Corona VaccinE tRiAL pLatform（COVERALL）的试点试验中，我们评估了瑞士首批两种获准的 SARS-CoV-2 疫苗的疫苗效力和试验平台的功能。
我们使用 Research Electronic Data Capture（REDCap）开发了一个集成 SHCS 和 STCS 基础设施的试验平台。一个确定合格患者的算法以及基线数据传输确保了合格患者的快速纳入程序。我们实施了不同数据录入系统之间的便捷重定向，以确保参与研究人员直观的数据录入。试验平台包括一个随机化算法，可确保不同亚组之间的平衡，并根据不断变化的疫苗接种政策持续进行调整。我们在收到伦理批准的同一天即可对第一位试验参与者进行随机分组和接种疫苗。招募并随机分配我们的 380 名患者的目标样本量的时间为 22 天。
我们充分利用每个系统的优势，能够标记合格患者，自动传输患者信息，以简单的工作流程对患者进行随机分组和入组，减少了与此类规模试验相关的行政负担。
