Department of Pharmaceutical and Pharmacological Sciences, Clinical Pharmacology and Pharmacotherapy, KU Leuven Leuven Belgium.
Centre for IT & IP Law (CiTiP), KU Leuven Leuven Belgium.
Eur J Health Law. 2020 Oct 21;27(5):425-450. doi: 10.1163/15718093-BJA10031.
The COVID-19 pandemic has severely disrupted non-coronavirus clinical trials. In the case of life-threatening diseases, such as cancer, this is particularly dangerous, as treatment cannot simply be stopped. In the EU, guidelines for the management of ongoing studies were issued; however, national coordination is still lacking. This article aims to raise awareness on the struggle of managing ongoing clinical trials in the EU during the pandemic. The goals are to bring attention, from a legal and regulatory point of view to the difficulties faced by those involved in clinical research, and to critically position the current hurdles against the backdrop of the existing legal and ethical framework. We investigated the EU guidance and the national approaches of all EU/EEA Member States, and critically discussed selected issues. We argue that the crisis may be an opportunity to foresee meaningful changes in the EU clinical trials framework post-COVID-19.
新冠疫情严重扰乱了非冠状病毒临床试验。在危及生命的疾病（如癌症）的情况下，这尤其危险，因为不能简单地停止治疗。在欧盟，发布了关于管理正在进行的研究的指南；然而，仍然缺乏国家协调。本文旨在提高对欧盟在大流行期间管理正在进行的临床试验的困境的认识。目标是从法律和监管的角度关注参与临床研究的人员所面临的困难，并在现有法律和伦理框架的背景下批判性地定位当前的障碍。我们调查了欧盟的指导意见以及所有欧盟/欧洲经济区成员国的国家方法，并对选定的问题进行了批判性讨论。我们认为，这场危机可能是在新冠疫情后预见欧盟临床试验框架有意义的变革的机会。
