Metadata-driven software for clinical trials

Authors:
Charles Crichton;Jim Davies;Jeremy Gibbons;Steve Harris;Andrew Tsui;James Brenton
Affiliations:
Oxford University Computing Laboratory, Wolfson Building, Parks Road, OX1 3QD, UK;Oxford University Computing Laboratory, Wolfson Building, Parks Road, OX1 3QD, UK;Oxford University Computing Laboratory, Wolfson Building, Parks Road, OX1 3QD, UK;Oxford University Computing Laboratory, Wolfson Building, Parks Road, OX1 3QD, UK;Oxford University Computing Laboratory, Wolfson Building, Parks Road, OX1 3QD, UK;Cancer Research UK, Cambridge Research Institute, Li Ka Shing Centre, RobinsonWay, CB2 0RE, UK
Venue:
SEHC '09 Proceedings of the 2009 ICSE Workshop on Software Engineering in Health Care
Year:
2009

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Abstract

The CancerGrid approach to clinical trials information systems is based on a metamodel developed from the CONSORT statement of best practice in reporting randomised controlled trials. The metamodel is instantiated with metadata elements drawn from a repository, to create a model of a particular clinical trial. The model is then used to derive automatically a trial management system customized for that trial: generating electronic case report forms, configuring randomisation and eligibility services, and parameterising the security subsystem. The key benefits of the approach are a uniform mechanism for trial registration and discovery, reduced cost and rapid implementation of information systems, and shared semantics leading to improved opportunities for meta-analysis. We describe our implementation of this approach, and outline two applications: for a breast cancer study in the UK, and for a rheumatoid arthritis study run by the US Veterans' Health Administration.