The emergence of the World Wide Web and related Internet technologies offers the potential of a shift in the paradigm for the collection and management of clinical research data for multi-site clinical trials. This new paradigm is characterized by a much closer interaction between the central coordinating site and the collaborating centers, which promises important benefits in the areas of cost-effectiveness, timeliness, data quality, and enhancement of patient safety. Before these benefits can be realized, the data management process used today to support large trials must be reengineered to take advantage of Internet technology. In Phase I, we will address several critical design areas: (l) rapid generation of databases and associated browser-based CRF pages for new clinical studies, (2) data security and access control, (3) production data entry with appropriate checking and help facilities, and (4) collaborative resolution of data discrepancies and information about adverse events. In each of these areas, we will prototype and evaluate one or more specific techniques utilizing information from an existing multi-center trial. In Phase II, we will collaborate with a clinical trials research organization to create and test a full prototype of an Internet-based clinical data management system.
We expect the technology developed in this project to lead to software tools which can be marketed to pharmaceutical companies and other research groups that perform clinical trials. Belmont Research has extensive experience in the design, development and marketing of computer software to support the clinical trials data collection and analysis process.
