COMMENTARY Open Access‘Cloud computing’ and clinical trials: reportfrom an ECRIN workshopChristian Ohmann 1,2* , Steve Canham 1 , Edgar Danielyan 3 , Steve Robertshaw 4 , Yannick Legré 5 , Luca Clivio 6and Jacques Demotes 1AbstractGrowing 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-dayworkshop on the topic to clarify potential benefits and risks. The issues that arose in that workshop are summarisedand include the following: the nature of cloud computing and the cloud computing industry; the risks in usingcloud computing services now; the lack of explicit guidance on this subject, both generally and with reference toclinical trials; and some possible ways of reducing risks. There was particular interest in developing and using aEuropean ‘community cloud’ specifically for academic clinical trial data. It was recognised that the day-longworkshop was only the start of an ongoing process. Future discussion needs to include clarification of trial-specificregulatory requirements for cloud computing and involve representatives from the relevant regulatory bodies.Keywords: Clinical trials, Cloud computing, Distributed computing, IT infrastructure, Security, Regulatory complianceBackgroundRecent years have seen rapidly growing interest in ‘cloudcomputing’, driven by the promise of cheap and flexible in-formation technology (IT) infrastructure available as a ser-vice, reducing the requirements for in-house systems andstaff. Trials units and vendors of clinical data managementsystems (CDMSs) are not immune to these temptations.Moreover, there are use cases in which cloud computingmay be a good fit (for instance, the aggregation of data formeta-analysis or the long-term curation of trial data).Within ECRIN-IA, an EU Seventh Framework Programme(FP7)-funded project, the European Organisation forResearch and Treatment of Cancer is developing VISTATrials, based on an existing widely used CDMS. Thecurrent need to explore options for this system’s deploy-ment serves as ECRIN’s own use case.The difficulty is that cloud computing technology bringsrisks as well as benefits. We need a better understandingof both, and we need to engage regulators to clarify thecriteria 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 com-mentary summarises the points that emerged that day.Main textThe commentary is based on a workshop. For that rea-son, no ethical approval was required and no informedconsent obtained.What is ‘cloud computing’?We see cloud computing as an extension of traditionaloutsourced IT provision, but confusion still surroundswhat the term ‘cloud computing’ means. We use the Na-tional Institute of Standards and Technology definition[1]: user-managed service configuration, rapid scalabilityand elasticity, and a metered cost model.The industry is growing very rapidly [2], exhibits fiercecompetition with (until very recently) rapidly decreas-ing costs [3], and is dominated by US-based companies,in particular Amazon (Seattle, WA, USA) and MicrosoftCorporation (Redmond, WA, USA) but also Google(Mountain View, CA, USA) and IBM Corporation(Armonk, NY, USA) [4].Though open or public clouds are the most common,it is possible to have cloud services limited to particular* Correspondence: christian.ohmann@med.uni-duesseldorf.de1 European Clinical Research Infrastructures Network (ECRIN), BioPark, 5-7 rueWatt, 75013 Paris, France2 European Clinical Research Infrastructure Network (ECRIN), Prinz-Georg-Str.51, 40477 Düsseldorf, GermanyFull list of author information is available at the end of the articleTRIALS© 2015 Ohmann et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution License(http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium,provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.Ohmann et al. Trials (2015) 16:318 DOI 10.1186/s13063-015-0835-6
