A Formal Representation for Numerical Data Presented in Published Clinical Trial Reports

Assessing the quality of and integrating clinical trial reports are necessary to practice evidence-based medicine. In particular, the numerical data is essential to understanding the strength and quality of the clinical trial study. In this paper, we present a formal representation for standardizing numerical data in published clinical trial reports, and our efforts towards developing computational tools to capture and visualize this representation. The approach includes two aspects: a process model used to precisely define experimental context behind the numerical value; and a spreadsheet, an intuitive and familiar tool used to organize numerical data. We demonstrated this representation using clinical trial reports on non-small cell lung cancer (NSCLC). We performed a preliminary evaluation to determine the usefulness of this formalism for identifying the characteristics, quality and significance of a clinical trial. Our initial results demonstrate that the representation is sufficiently expressive to capture reported numerical information in published papers.