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Beyond the Web: A Decentralised Approach to Data Collection from Multi- Centric Clinical Trials by Virtual Organizations Using Peer-To-Peer Data Sharing

Luca Clivio, Lital Hollander, Luca Beltrame and Anthony J Travis

Harnessing the power of ‘disruptive’ technologies in a peer-to-peer network is a cost-effective way for non-profit research organizations to manage their clinical trials data and provide decentralised control to ensure clinical trials are conducted for the benefit of patients rather than for any one of the collaborating laboratories. Sharing data between multiple centres is important in clinical research to reduce any selection bias of patients participating in a trial when the patients involved at any one centre may not be representative of the population as a whole and the number of patients needed for a statistically meaningful result is greater than one centre can provide. Regulation of data sharing in clinical trials is essential to avoid accidental loss of data and to maintain control of access to data. Regular backups and measures to restrict unauthorised access to the data are an essential part of quality control for regulatory compliance of clinical data collection tasks. FDA CFR 21 part 11, which is an important regulation for clinical trials, explicitly require this level of compliance. Avoiding accidental 'prior-disclosure' of data and preventing unauthorised or inappropriate use of it is important for the correct attribution of work done by clinical research scientists. Many aspects of clinical research rely on ‘virtual organizations’ because management of clinical research projects often spans institutional boundaries to avoid duplication of effort and to share resources in order to solve problems economically. Clinical researchers working in different laboratories collaborate and share their data. The laboratories involved need to develop trust relationships to share data and intellectual property. This requires agreement about data management: In particular, where to store the shared data, which will curate it, who has access to it and how to share the data. In this paper we discuss a cost-effective and decentralised network-based approach to management of clinical data that disrupts established practice of using a centralised web-based database for all aspects of managing clinical trials data.