Exploiting Ontology Based Search and EHR Interoperability to Facilitate Clinical Trial Design

Clinical trials often fail to demonstrate beneficial effects and might overestimate the unwanted effects, with their results having low external validity. They focus on single interventions, whereas the clinical practice environment comprises various features that affect the efficacy, feasibility, duration and costs of a clinical trial. In this chapter we discuss PONTE, a platform which effectively guides medical researchers through clinical trial protocol design and offers intelligent services that address clinical needs, such as effective inclusion/exclusion criteria specification, intelligent search through a wide range of databases, clinical findings and background knowledge, and automated estimation of eligible patient population at cooperating healthcare entities. To the best of our knowledge, and to date, the PONTE platform is the first paradigm of an automated system that can effectively guide clinical trials protocol design, by linking data with drug, target and disease knowledge databases, clinical care and clinical research information systems, and guiding the users automatically though the whole pipeline of the clinical trial protocol design.