Form Follows Function: Model−Driven Engineering for Clinical Trials

Abstract

For certain constrained domains,elaborate model transformation technologies - implemented from scratch in general-purpose programming languages - are unnecessary for model-driven engineering; instead, lightweight configuration of commercial off-the-shelf productivity tools suffices. In this paper, we consider the generation of software tools to support clinical trials. A domain metamodel captures the community's best practice in trial design. A scientist authors a trial protocol, modelling their trial by instantiating the metamodel; customized software artifacts to support trial execution are generated automatically from the scientist's model. The metamodel is expressed as an XML Schema, in such a way that it can be instantiated by completing a form to generate a conformant XML document. The same process works at a second level for trial execution: among the artifacts generated from the protocol are models of the data to be collected, and observations are reported by completing a form to create a conformant XML document. Simple standard form management tools are all that is needed.