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.

该COVID -19流行已严重扰乱了非冠状病毒的临床试验。对于威胁生命的疾病，例如癌症，这尤其危险，因为不能简单地停止治疗。在欧盟，发布了进行中研究管理指南；但是，仍然缺乏国家协调。本文旨在提高人们对大流行期间欧盟正在进行的临床试验管理工作的认识。目标是从法律和法规的角度吸引关注临床研究人员所面临的困难，并将当前的障碍严格地置于现有法律和道德框架的背景下。我们调查了欧盟指南和所有欧盟/欧洲经济区的国家措施会员国，并严格讨论了选定的问题。我们认为，危机可能是预见COVID -19之后欧盟临床试验框架中有意义变化的机会。