'Cloud computing' and clinical trials: report from an ECRIN workshop

• Published in: Current controlled trials in cardiovascular medicine Vol. 16; no. 1; p. 318
• Main Authors: Ohmann, Christian, Canham, Steve, Danielyan, Edgar, Robertshaw, Steve, Legré, Yannick, Clivio, Luca, Demotes, Jacques
• Format: Journal Article Conference Proceeding
• Language: English
• Published: England BioMed Central Ltd 29.07.2015; BioMed Central
• Subjects: Certification; Clinical trials; Clinical Trials as Topic - methods; Clinical Trials as Topic - standards; Cloud computing; Cloud Computing - standards; Computer Security; Computer software industry; Conferences, meetings and seminars; Costs; Guidelines as Topic; Humans; Infrastructure; ISO standards; Medical research; Medicine, Experimental; Product development; Research Design - standards; Risk Assessment; Workshops (Educational programs); Belgium; United States; United Kingdom > UK; United States > US; Europe
• ISSN: 1745-6215; 1745-6215
• 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.