Abstract
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.
Highlights
The commentary is based on a workshop
The European Clinical Research Infrastructures Network (ECRIN) workshop was a beginning; there were more questions raised than questions answered
We urgently need to characterise the acceptable use of cloud computing for clinical trials
Summary
Recent years have seen rapidly growing interest in ‘cloud computing’, driven by the promise of cheap and flexible information technology (IT) infrastructure available as a service, reducing the requirements for in-house systems and staff. There are use cases in which cloud computing may be a good fit (for instance, the aggregation of data for meta-analysis or the long-term curation of trial data). Within ECRIN-IA, an EU Seventh Framework Programme (FP7)-funded project, the European Organisation for Research and Treatment of Cancer is developing VISTA Trials, based on an existing widely used CDMS. The difficulty is that cloud computing technology brings risks as well as benefits. We need a better understanding of both, and we need to engage regulators to clarify the criteria by which cloud computing services can be judged. ECRIN organised a one-day workshop (30 Oct. 2014, Brussels, Belgium) to instigate this process, and this commentary summarises the points that emerged that day
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