Djurisic Snezana, Rath Ana, Gaber Sabrina, Garattini Silvio, Bertele Vittorio, Ngwabyt Sandra-Nadia, Hivert Virginie, Neugebauer Edmund A M, Laville Martine, Hiesmayr Michael, Demotes-Mainard Jacques, Kubiak Christine, Jakobsen Janus C, Gluud Christian
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Orphanet, Institut National de la Santé et de la Recherche Médicale (INSERM), Paris, France.
Trials. 2017 Aug 1;18(1):360. doi: 10.1186/s13063-017-2099-9.
Randomised clinical trials are key to advancing medical knowledge and to enhancing patient care, but major barriers to their conduct exist. The present paper presents some of these barriers.
We performed systematic literature searches and internal European Clinical Research Infrastructure Network (ECRIN) communications during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project.
The following barriers to randomised clinical trials were identified: inadequate knowledge of clinical research and trial methodology; lack of funding; excessive monitoring; restrictive privacy law and lack of transparency; complex regulatory requirements; and inadequate infrastructures. There is a need for more pragmatic randomised clinical trials conducted with low risks of systematic and random errors, and multinational cooperation is essential.
The present paper presents major barriers to randomised clinical trials. It also underlines the value of using a pan-European-distributed infrastructure to help investigators overcome barriers for multi-country trials in any disease area.
随机临床试验是推动医学知识进步和改善患者护理的关键，但开展此类试验存在重大障碍。本文介绍了其中一些障碍。
在欧洲临床研究基础设施网络（ECRIN）整合活动（ECRIN-IA）项目的背景下，我们于2013年至2017年期间在面对面会议和电话会议中进行了系统的文献检索和ECRIN内部沟通。
确定了随机临床试验存在以下障碍：临床研究和试验方法知识不足；资金缺乏；监测过度；隐私法限制且缺乏透明度；监管要求复杂；基础设施不足。需要开展更多具有低系统误差和随机误差风险的务实随机临床试验，跨国合作至关重要。
本文介绍了随机临床试验的主要障碍。它还强调了利用泛欧分布式基础设施帮助研究人员克服任何疾病领域多国试验障碍的价值。
