Towards a clinical trial ontology using a Concern-Oriented-Approach

Authors

  • Crenguta Bogdan
  • Daniela Luzi
  • Fabrizio L. Ricci
  • Luca D. Serbanati

DOI:

https://doi.org/10.14600/irpps_wps.10.2006

Keywords:

Clinical trial, Selection criteria, Ontology, Concerns

Abstract

To reduce costs and enhance the research quality in clinical trials (CT) a more systematic approach is needed for CT automatization as well as for enhancing interoperability at various levels of the research process. To this aim a conceptual model of CTs should be developed. At the base of any modelling approach there are partitioning criteria which enable us to dominate the complexity of the modelled universe. In this report we introduce an original analysis method based on stakeholders’ concerns to partition the CT conceptual domain in stakeholder-oriented sub-domains. Mental representations of stakeholders related to each concern are identified as clusters of concepts related to each other. We consider such a cluster as a semantic rationale for the associated concern. The concepts found in the semantic rationales populate the universe of discourse specific to each stakeholder and compose the stakeholder’s vocabulary. Some concepts are shared with other stakeholders while others are specific to one stakeholder, some concepts are CT specific while others are medical or general concepts. In this way a concern-oriented ontology of the CT can be created. The method is illustrated for the subject selection criteria, a component of a CT project, but it can be used for any other component of the CT protocol. The taxonomy of the vocabulary of CT concepts and the relative semantic rationale net give us a valuable structure for software development especially in solutions based on a service-oriented architecture.

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Published

2006-10-12

How to Cite

Bogdan, C., Luzi, D., Ricci, F. L., & Serbanati, L. D. (2006). Towards a clinical trial ontology using a Concern-Oriented-Approach. IRPPS Working Papers, 1–26. https://doi.org/10.14600/irpps_wps.10.2006

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Section

Working Papers