Clinical Study to SVG

This presentation will show the transformation of clinical trial study data into SVG. The starting point is the Clinical Data Interchange Standards Consortium's (CDISC) Operation Data Model (ODM) version 1.2. The ODM schema captures meta-data and data of clinical trials for analysis and submission to regulatory authorities such as the Food and Drug Administration of the United States. This new ODM version (December 2003), as the previous ones, aims to simplify transfer of clinical trial data between investigators and regulators.

Clinical study data is routinely tabulated and graphed for analytical purposes and for regulatory submissions. Using XSLT, tables and graphs of study results and events are generated from an ODM XML instance. SVG graphs of subjects' pharmacokinetic profiles for each arm of the study are produced and embedded into an XHTML page. To simulate the impact of different results on the pharmacokinetic profile, it is possible to change the data on the web page and update the SVG graphs on-the-fly. In addition, demographics data and study events, such as adverse events, are tabulated and SVG graphs are produced to provide summaries. Basic pharmacokinetic and statistical parameters are also derived from the ODM instance with XSLT and JavaScript. The ODM could be alternatively styled into clinical reports in PDF format with XSL-FO.

This research gives an example of how a web application could use an ODM version 1.2 instance as input for clinical trial analysis and regulatory submission preparation using stylesheets and interactive SVG.