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

✍ Scribed by Michael N. Pollak

• Publisher: Elsevier Science
• Year: 1983
• Weight: 962 KB
• Volume: 16
• Category: Article
• ISSN: 0010-468X
• DOI: 10.1016/0010-468x(83)90086-7

✦ Synopsis

Clinical trials involve the administration of new or experimental treatments to patients and the ~ubsequent observation of responses to these treatments ever 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 :or iinal 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 or patients, increasing length of follow-up period, increasing numbers ¢f 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 desi~tmed to solve data management problems as perceived by the clinical re.archer is described. Clinical trials Clinical research Computer-aided medical informalion management * M.N. Pollak (MD.. F.R.C.P.(C)) is currently a Terrs' Fox Fellow at the Ontario Cancer Institute, 500 Sherbourne the various treatment grot.ps are frequently re-Street, Toromo, Ontario. M4X I Kg, Canada quired for ethical as wel! as sci,=ntific reasons.