Clinical Trials Data Management in the Big Data Era.

The Department of Veterans Affairs (VA) Cooperative Studies Program (CSP), Clinical Research Pharmacy Coordinating Center (Center) has supported clinical trials for more than four decades. Managing information from clinical trials and published results in the Big Data era presents new challenges and opportunities. These include and are not limited to data attribution, aggregation, adaptability, and prompt analysis. Hence, the Center has created a dynamic application to present a broad understanding of the clinical trials’ achievements. To collect crucial information from clinical trials, this application includes 1) data attribution to identify provenance and to preserve relationships between trials and resulting publications, 2) data normalization to deal with variety of formats and concepts, 3) data aggregation to integrate information from different trials, and 4) data analysis with a friendly interface to consult aggregated information promptly. This work establishes a Semantic Data Model for each clinical trial to create a summary of key information in a machine-readable format, and to enrich each summary with semantic information. In addition, it allows the union of these models to represent a global knowledge source from a set of clinical trials. The organized models offer compatibility and interoperability within and among clinical trials.