Towards Semantic Interoperability in a Clinical Trials Management System

Abstract

Abstract.Clinical trials are studies in human patients to evaluate the safety and effectiveness of new therapies. Managing a clinical trial from its inception to completion typically involves multiple disparate applications facilitating activities such as trial design specification, clinical sites management, participants tracking, and trial data analysis. There remains however a strong impetus to integrate these diverse applications -each supporting different but related functions of clinical trial management -at syntactic and semantic levels so as to improve clarity, consistency and correctness in specifying clinical trials, and in acquiring and analyzing clinical data. The situation becomes especially critical with the need to manage multiple clinical trials at various sites, and to facilitate meta-analyses on trials. This paper introduces a knowledge-based framework that we are building to support a suite of clinical trial management applications. Our initiative uses semantic technologies to provide a consistent basis for the applications to interoperate. We are adapting this approach to the Immune Tolerance Network (ITN), an international research consortium developing new therapeutics in immune-mediated disorders.

An Information System to Support and Monitor Clinical Trial Process

“…This often makes it necessary to develop tailored databases from scratch to manage new clinical studies. Moreover, the integration between these different legacy systems [7] is still a crucial issue, considering, on the one hand, the variety of both data and knowledge to be managed, and on the other the need to make these systems interoperable with external ones (Electronic medical records, laboratory systems, registries, etc.) [8][9][10].…”

The Semantic Web and Human Inference: A Lesson from Cognitive Science

“…With the advent of genome research, individuals' genomic information will also become available to clinicians in the future, and doctors will be increasingly fraught with individuated information. By developing inference agents tailored for specific patents, medical diagnosis can be facilitated significantly by using the Semantic Web technology [13] [14].…”