Ohmann Christian, Canham Steve, Danielyan Edgar, Robertshaw Steve, Legré Yannick, Clivio Luca, Demotes Jacques
European Clinical Research Infrastructures Network (ECRIN), BioPark, 5-7 rue Watt, 75013, Paris, France.
European Clinical Research Infrastructure Network (ECRIN), Prinz-Georg-Str. 51, 40477, Düsseldorf, Germany.
Trials. 2015 Jul 29;16:318. doi: 10.1186/s13063-015-0835-6.
Growing use of cloud computing in clinical trials prompted the European Clinical Research Infrastructures Network, a European non-profit organisation established to support multinational clinical research, to organise a one-day workshop on the topic to clarify potential benefits and risks. The issues that arose in that workshop are summarised and include the following: the nature of cloud computing and the cloud computing industry; the risks in using cloud computing services now; the lack of explicit guidance on this subject, both generally and with reference to clinical trials; and some possible ways of reducing risks. There was particular interest in developing and using a European 'community cloud' specifically for academic clinical trial data. It was recognised that the day-long workshop was only the start of an ongoing process. Future discussion needs to include clarification of trial-specific regulatory requirements for cloud computing and involve representatives from the relevant regulatory bodies.
云计算在临床试验中的使用日益增加,这促使欧洲临床研究基础设施网络(一个为支持跨国临床研究而成立的欧洲非营利组织)组织了一次关于该主题的为期一天的研讨会,以阐明潜在的益处和风险。该研讨会中出现的问题总结如下:云计算的本质和云计算行业;目前使用云计算服务存在的风险;总体上以及针对临床试验而言,在这个问题上缺乏明确的指导;以及一些降低风险的可能方法。人们对专门为学术临床试验数据开发和使用欧洲“社区云”特别感兴趣。人们认识到,为期一天的研讨会仅仅是一个持续过程的开端。未来的讨论需要包括明确针对云计算的特定试验监管要求,并让相关监管机构的代表参与进来。