C. Crichton, J. Davies, J. Gibbons, Steve Harris, Andrew Tsui, J. Brenton
{"title":"Metadata-driven software for clinical trials","authors":"C. Crichton, J. Davies, J. Gibbons, Steve Harris, Andrew Tsui, J. Brenton","doi":"10.1109/SEHC.2009.5069600","DOIUrl":null,"url":null,"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.","PeriodicalId":173217,"journal":{"name":"2009 ICSE Workshop on Software Engineering in Health Care","volume":"57 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2009-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"19","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"2009 ICSE Workshop on Software Engineering in Health Care","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1109/SEHC.2009.5069600","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 19
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.