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Metadata-driven software for clinical trials

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. © 2009 IEEE.
Authors:
C Crichton, J Davies, J Gibbons, S Harris, A Tsui, J Brenton
Journal:
Proceedings of the 2009 ICSE Workshop on Software Engineering in Health Care, SEHC 2009
Citation info:
:1-11
Publication date:
19th Oct 2009
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