Jedličková Anetta
Vnitr Lek. 2022 Winter;68(E-1):9-15.
The paper focuses on conducting clinical trials on medicinal products for human use during the COVID-19 pandemic, which has brought entirely new ethical dilemmas to clinical research professionals, as well as to the general public. Growing ethical concerns emphasized the need for partially modified or completely new procedures in order to ensure the safety of clinical trial participants, compliance with good clinical practice, and minimizing risks to the clinical trial integrity and validity of data obtained from clinical trials conducted during the pandemic. The paper acquaints with emergency measures issued by the State Institute for Drug Control during the COVID-19 public health emergency, discusses quality management, methods of efficient verification of the safety of subjects and data validity, and last but not least, presents risk areas and their ethical aspects in conducting clinical trials during the COVID-19 pandemic.
本文聚焦于在新冠疫情期间开展用于人类的医药产品临床试验,这给临床研究专业人员以及普通公众带来了全新的伦理困境。日益增加的伦理担忧凸显了部分修改或全新程序的必要性,以确保临床试验参与者的安全、符合良好临床实践,并将对临床试验完整性以及疫情期间所进行临床试验获得的数据有效性的风险降至最低。本文介绍了国家药品监督管理机构在新冠公共卫生紧急事件期间发布的紧急措施,讨论了质量管理、有效核查受试者安全性和数据有效性的方法,最后但同样重要的是,呈现了新冠疫情期间开展临床试验的风险领域及其伦理方面。