A Method for the Detection and Management of Adverse Events in Clinical Trials

Abstract

This paper describes a systematic approach to the detection, classification, and documentation of adverse events in a multicenter clinical trial. The system is designed to minimize investigator prejudgment, capture infrequent or unexpected adverse effects, track concurrent adverse events, and allow for comparison of effects across clinical centers. The method employs a standard questionnaire, which records health status and symptomatology of the patient at study entry as well as at follow-up visits to allow comparison. A systems review, to detect emerging or changing symptoms, is also included. The association of the adverse events to the study drug is classified according to standard criteria. All adverse events, whether or not judged to be drug related, are recorded. Dose modifications are prescribed and documented at each follow-up visit until the adverse event is resolved. This system combines standard methodology with continuous monitoring to provide a comprehensive approach to managing adverse event...