An Ontology for Clinical Trial Data Integration

A set of well-integrated clinical terminologies is at the core of delivering an efficient clinical trial system. The design and outcomes of a clinical trial can be improved significantly through an unambiguous and consistent set of clinical terminologies used in a participating clinical institute. However, due to lack of generalised legal and technical standards, heterogeneity exists between prominent clinical terminologies as well as within and between clinical systems at several levels, e.g., data, schema, and medical codes. This article specifically addresses the problem of integrating local or proprietary clinical terminologies with the globally defined universal concepts or terminologies. To deal with the problem of ambiguous, inconsistent, and overlapping clinical terminologies, domain and knowledge representation specialists have been repeatedly advocated the use of formal ontologies. We address two key challenges in developing an ontology-based clinical terminology (1) an ontology building methodology for clinical terminologies that are separated in global and local layers, and (2) aligning global and local clinical terminologies. We present Semantic Electronic Health Record (SEHR) ontology that covers multiple sub-domains of Healthcare and Life Sciences (HCLS) through specialisation of the upper-level Basic Formal Ontology (BFO). One of the main features of SEHR is layering and adaptation of local clinical terminologies with the upper-level BFO. Our empirical evaluation shows an agreement of clinical experts confirming SEHR´s usability in clinical trials.