The increasing complexity of clinical trials has generated an enormous requirement for knowledge and information specification at all stages of the trials, including planning, documentation, implementation, and analysis. We are building a knowledge-based framework (Epoch) to support the management of clinical trials. We are tailoring this approach to the Immune Tolerance Network (ITN), an international research consortium developing new therapeutics in immune-mediated disorders. In the broad spectrum of trial management activities, we currently target two areas that are vital to the successful implementation of a trial: (1) tracking study participants as they advance through the trials, and (2) tracking biological specimens as they are processed at the trial laboratories. The core of our software architecture is a suite of ontologies that conceptualizes relevant clinical trial domain. Our approach can provide ITN and other research organizations a stable and consistent knowledge source for clinical-trial software applications.
