TRIAL MASTER, an expert system to control clinical drug trials

Abstract

An expert system has been designed to facilitate the proper application of inclusion and exclusion criteria for clinical drug trials. For six trials, these criteria were represented in rules and stored in knowledge bases. In three cases, a separate knowledge base was added, containing knowledge on ECG (electrocardiographic) criteria. For a series of 100 patients, the cardiologist and the expert system disagreed with regard to three patients. In 24 cases the patient was classified for at least one trial; 73 patients did not meet the requirements for inclusion in any trial. As an example, the evaluation of a patient with unstable angina is presented.<>