Form Follows Function: Model-Driven Engineering for Clinical Trials

Abstract

Abstract. We argue that, for certain constrained domains, elaborate model transformation technologies-implemented from scratch in generalpurpose programming languages-are unnecessary for model-driven engineering; instead, lightweight configuration of commercial off-the-shelf productivity tools suffices. In particular, in the CancerGrid project, we have been developing model-driven techniques for 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 the clinician conducting the trial instantiates such models in reporting observations-again by completing a form to create a conformant XML document, representing the data gathered during that observation. Simple standard form management tools are all that is needed. Our approach is applicable to a wide variety of information-modelling domains: not just clinical trials, but also electronic public sector computing, customer relationship management, document workflow, and so on.It is the pervading law of all things organic and inorganic, Of all things physical and metaphysical, Of all things human and all things super-human, Of all true manifestations of the head, Of the heart, of the soul, That the life is recognizable in its expression, That form ever follows function. This is the law.