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(English) (Italiano) Towards a clinical trial ontology using a Concern-Oriented-Approach

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

    (English) 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. (Italiano) Per ridurre i costi e migliorare la qualita’ della ricerca nei trial clinici (CT) e’ necessario un approccio piu’ sistematico all’automazione dei CT per rinforzare l’interoperabilita’ a vari livelli del processo di ricerca. Per questo scopo e’ stato sviluppato un modello concettuale di CT. Alla base di ogni approccio di modellizzazione ci sono criteri di partizione che ci permettono di dominare la complessita’ dell’universo da modellare. In questo rapporto noi introduciamo un metodo originale di analisi basato sui concern degli stakeholder per partizionare il domino concettuale dei CT in sotto-domini orientati agli stakeholder. Le rappresentazioni mentali degli stakeholder relative a ciascun concern sono identificati come cluster di concetti collegati ad altri concetti. Noi consideriamo ciascun cluster come una base razionale per il relativo concern. I concetti trovati nelle basi razionali popolano l’universo del discorso specifico per ogni stakeholder e compongono il vocabolario degli stakeholder. Alcuni concetti sono condivisi con altri stakeholder, mentre altri sono specifici di uno stakehoder; alcuni concetti sono specifici dei CT, mentre altri sono concetti medici o generali. In questo modo un’ontologia orientata ai concern per i CT puo’ essere creata. Il metodo e’ illustrato utilizzando i criteri di selezione dei soggetti, una componente di un progetto di CT, ma puo’ essere usato per ogni altra componente del protocollo del CT. La tassonomia del vocabolario dei concetti dei CT e la rete delle relative basi razionali ci fornisce una struttura possibile per lo sviluppo del software specialmente se si adotta una soluzione basata su architetture orientate ai servizi.

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    Bibliographic Info

    Paper provided by National Research Council, Institute for Research on Population and Social Policies in its series IRPPS Working Papers with number 10:2006.

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    Date of creation: 2006
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    Handle: RePEc:cnz:wpaper:10:2006

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    Keywords: (English) Clinical trial; Selection criteria; Ontology; Concerns (Italiano) Trial clinici; Criteri di selezione; Ontologia; Concern;

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