Design aspects of a distributed clinical trials information system

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Abstract
Backgound Clinical trials informatics has evolved through the development of multiple applications addressing distinct parts of the clinical trials cycle. This setting creates difficulties in the transport and sharing of data among applications that serve a common functionality. Purpose We present an alternative approach for the design of clinical trials information systems consisting of loosely coupled components standing on a comprehensive model of the global clinical trial process. Methods We describe how such a structure is able to support the development and implementation of complex knowledge-driven modules, such as automated database query systems, reporting systems and intelligent data-analysis tools, and how currently available internet technologies may be used to support the independent development of applications and collaboration between researchers. Results These principles were applied to the development of a fully functional system that has been in production for eight years in a diversity of pharmaceutical and academic drug trials. Marked time savings in database set-up and statistical reporting have been documented, as well as good reliability in the selection of appropriate statistical methods to clinical trial data analysis. Conclusions In order to meet the expected functionality and to avoid the proliferation of databases and software applications, clinical trials information systems need to be based on a generic model of clinical trials and on a distributed architecture.

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