The main objective of this proposal is to improve the development and administration of clinical trials by developing an innovative state-of-the-art distributed electronic clinical trial management system along with an integrated suite of clinical trial development tools. The proposed system effectively interacts with clinical trial developers, clinical investigators, and staff conducting clinical trials, and interfaces with external data sources in order to provide efficient end-to-end clinical trial data acquisition, management, and analysis. The integrated suite of clinical trial development tools enables clinical investigators to easily design clinical forms and trial protocols through a graphical user interface, while automating the tasks of form and protocol representation, database creation and configuration, and interfacing with external data sources. The proposal builds upon the technical feasibility established during phase I in four key areas: (1) electronic representation of clinical trial protocols, forms, and data using the open extensible Markup Language (XML); (2) design of a web-based trial administration tool incorporating decision support logic to generate clinical alerts for handling adverse events; and (3) architecture of a clinical trial development environment for enabling the definition of custom clinical trial protocols and forms; and (4) development of a novel technique for automated generation of the clinical trial database and associated synchronization schemes among sites participating in a clinical trial. The inherent automation, customization, portability and scalability characteristics of the proposed system establish its potential for efficient and effective management of a wide range of clinical trials involving multiple sites and varying requirements, complexities, and protocols. In the context of this proposal, the system will be evaluated and assessed in terms of clinical acceptance and usability through close collaboration with clinical consultants.
