期刊
JOURNAL OF BIOMEDICAL INFORMATICS
卷 52, 期 -, 页码 78-91出版社
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.jbi.2013.11.002
关键词
Ontology; Clinical research; Eligibility criteria; Clinical research informatics; Evidence-based medicine; Trial registration
资金
- National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH) [LM-06780, RR026040, UL1RR025005, UL1RR024143, UL1RR024131, UL1RR025767]
- NIH Roadmap for Medical Research
To date, the scientific process for generating, interpreting, and applying knowledge has received less informatics attention than operational processes for conducting clinical studies. The activities of these scientific processes - the science of clinical research - are centered on the study protocol, which is the abstract representation of the scientific design of a clinical study. The Ontology of Clinical Research (OCRe) is an OWL 2 model of the entities and relationships of study design protocols for the purpose of computationally supporting the design and analysis of human studies. OCRe's modeling is independent of any specific study design or clinical domain. It includes a study design typology and a specialized module called ERGO Annotation for capturing the meaning of eligibility criteria. In this paper, we describe the key informatics use cases of each phase of a study's scientific lifecycle, present OCRe and the principles behind its modeling, and describe applications of OCRe and associated technologies to a range of clinical research use cases. OCRe captures the central semantics that underlies the scientific processes of clinical research and can serve as an informatics foundation for supporting the entire range of knowledge activities that constitute the science of clinical research. (C) 2013 Elsevier Inc. All rights reserved.
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