TrialWiz: an ontology-driven tool for authoring clinical trial protocols.

There has long been great interest in the clinical research community for automated support of clinical trials management. At the core of such efforts is formal specification of protocol knowledge. Building a clinical-trial knowledge base is a complex task involving software engineers and domain experts. As part of our Epoch ontological framework for clinical trials management, we have developed TrialWiz, an authoring tool for encoding a clinical-trial knowledge base. The main goals of TrialWiz are to manage the complexity of the protocol-encoding process and to improve efficiency in knowledge acquisition. TrialWiz provides intelligent guidance through the process of acquiring clinical-trial knowledge; graphical user interfaces intuitive to clinical trialists; a repository of reusable knowledge; and facilities to export the knowledge in different formats. We have successfully used TrialWiz to encode example clinical trials at the Immune Tolerance Network (ITN). In this presentation, we will demonstrate the intuitive authoring of clinical trial protocols using TrialWiz and how the protocol knowledge can be used by different clinical trial management applications at run time.