Development and Evaluation of a Knowledge-Based System to Assess a Drug's Safety Profile from Laboratory Data

Abstract

An important step in assessing the safety profile of a drug is the monitoring and careful evaluation of the laboratory data collected during clinical trials. Using a commercially available development tool for PC-based systems, a prototype knowledge-based system to aid in the process of interpretation of laboratory data in order to evaluate the safety profile of a drug in different stages of development has been created. At present, the system comprises more than 120 rules. Its integration with the database of clinical trials allows minimal input by the user and produces results which can be readily displayed and processed. A system evaluation has been performed with the data collected during a multicenter clinical trial in which efficacy and safety of a drug were tested in the treatment of subarachnoid hemorrhage; in this trial 17 laboratory test values were collected twice in 128 patients. The system exhibited a satisfactory level of performance, comparable or better than that of two human experts.

Keywords

Laboratory data monitoring Knowledge-based systems Drug safety Clinical trials

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