Introduction: The overall objective of this project is to design a scalable distributed research network (DRN) that supports secure data analyses for research on the comparative effectiveness and safety of therapeutics. The plan for achieving this objective includes designing an information system architecture, implementation of a prototype of the specified system architecture, and completion of a proof of concept pilot project conducted in partnership with the Agency for Healthcare Research and Quality (AHRQ).
Methods: Systems already implemented by the HMORN provide the foundation for the development of this DRN. These include established procedures for: 1) use of decentralized data files that remain in possession of the covered entities; 2) governance methods emphasizing local control and decision-making about participation in research projects; 3) transparency in choosing projects, protocol development, and communication of results; and 4) best practices for preserving privacy, ensuring data integrity, and accurate data interpretation.
DRN System Architecture: The DRN architecture is being modeled as a federation of separate, heterogeneous databases that will be accessible through a common exchange model, implemented as a common query system (CQS). Under the common exchange model, heterogeneous data and systems do not need to be physically integrated, but the model affords interoperability, such that users can access these data resources using a single interface using a common syntax and semantic representation of data elements and coding schemes. This is a distinct advantage for the DRN, since there will be different data resource providers, some of which place strict constraints on the use of data. The common exchange model obviates the need for users to learn the syntactic and semantic characteristics of the resources available across the entire DRN.
Prototype Development: The DRN is being developed using a rapid prototype life-cycle. This user centered approach employs incrementally developed system prototypes such that all participants become stakeholders in the development process and have access to increasingly complex, concrete representations of the final system.