Computer-aided information management systems in clinical trials. A physician's perspective.

Clinical trials involve the administration of new or experimental treatments to patients and the subsequent observation of responses to these treatments over appropriate periods of time. During a clinical trial, large volumes of data describing the course of each patient must be gathered and analyzed. Traditionally, computers have been used only for final statistical calculations after labour-intensive data capture and tabulation. These methods are becoming increasingly expensive, and problems with traditional data management techniques in clinical research are compounded by trends including increasing numbers of patients, increasing length of follow-up period, increasing numbers of relevant treatment and response variables, and participation of geographically dispersed research groups in 'multicentre' trials. Existing computer systems to aid with data management in clinical research are reviewed and criticized, and a new system designed to solve data management problems as perceived by the clinical researcher is described.