Towards a Flexible Semantic Framework for Clinical Trial Eligibility using Topic Maps

Clinical trials are conducted extensively in clinical research. Most often, the eligibility screening consists of manually reviewing individual (patient) health records to identify potential candidates. Automated selection can improve the selection accuracy, increase the number of selected patients, and reduce the cost of the selection process. A formal representation of clinical trial eligibility criteria is however required to facilitate such automated selection and also to enable efficient multi-centric screening, thereby dealing with heterogeneous data coming from disparate sources. We present a novel framework to represent clinical trial eligibility criteria based on Topic Maps. The framework addresses the needs in multi-centric screening by allowing for flexible and decentralized creation, sharing and integration of clinical trial representations and eligibility concepts. This is achieved through a formal but locally extensible ontology, thereby enabling unified querying across multiple institutions. Topic Maps is a semantic knowledge representation technology for describing data and information. An ontology was created that describes the building blocks of a clinical trial. This representation encapsulates institution-specific data sources, thereby providing a domain-centric view on clinical trial definitions. Additionally, an evaluation engine was developed to assess patient eligibility using the ontology. A proof-of-concept was implemented at the Antwerp University Hospital. We show how the use of Topic Maps can facilitate patient recruitment across different centers. Permission to make digital or hard copies of all or part of this work for personal or classroom use is granted without fee provided that copies are not made or distributed for profit or commercial advantage and that copies bear this notice and the full citation on the first page. To copy otherwise, to republish, to post on servers or to redistribute to lists, requires prior specific permission and/or a fee. HI-KDD ’12, August 12, 2012, Beijing, China Copyright 2012 ACM 978-1-4503-1548-7/12/08... $15.00.