Columbia University
Department of Biomedical Informatics
Vanderbilt Clinic VC5 
622 W 168th St.
New York, NY  10032

Clinical research is an extremely complex process involving large numbers of stakeholders over extended time periods. Information is vital to all research activities, from conception of the protocol, through execution, to dissemination of results. Poor information flow directly contributes to lack of quality in research and high cost due to slow manual processes, introduction of errors and the inability to combine information from fragmentary or isolated sources. Unfortunately, information technology has had little penetration into the clinical research enterprise. Most of this effort has concentrated on trials in academic medical centers. The needs of investigators in community settings differ in striking ways, and are not adequately served by software provided by industry sponsors.

We have developed a successful working clinical trials network of 39 community practice research sites with centralized administration located at an academic medical center. Clinical research networks offer certain economies of scale by providing access to sufficiently large subject populations, standardizing best practices and centralizing administrative, financial, regulatory, and educational activities. However, the efficiency and expansion of the network are limited by the lack of information technology resources. The broad, long-term objectives of this proposal are to address these limitations by improving the information flow among investigators, administrators and participants.