Reengineering a Database for Clinical Trials Management: Lessons for System Architects

• Published in: Controlled clinical trials 2000-10, Vol.21 (5), p.440-461
• Main Authors: Brandt, Cynthia A, Nadkarni, Prakash, Marenco, Luis, Karras, Bryant T, Lu, Charles, Schacter, Lee, Fisk, John M, Miller, Perry L
• Format: Article
• Language: English
• Subjects: Biological and medical sciences; Clinical trial. Drug monitoring; Clinical trials; Clinical Trials as Topic; Database Management Systems; Databases as Topic; General pharmacology; Medical sciences; Pharmacology. Drug treatments; relational database systems; World Wide Web database applications
• ISSN: 0197-2456; 1879-050X
• DOI: 10.1016/S0197-2456(00)00070-2

This paper describes the process of enhancing Trial/DB, a database system for clinical studies management. The system's enhancements have been driven by the need to maximize the effectiveness of developer personnel in supporting numerous and diverse users, of study designers in setting up new studies, and of administrators in managing ongoing studies. Trial/DB was originally designed to work over a local area network within a single institution, and basic architectural changes were necessary to make it work over the internet efficiently as well as securely. Further, as its use spread to diverse communities of users, changes were made to let the processes of study design and project management adapt to the working styles of the principal investigators and administrators for each study. The lessons learned in the process should prove instructive for system architects as well as managers of electronic patient record systems. Control Clin Trials 2000;21:440–461