Toward a Model of Clinical Trials

In the paper some results of the modelling of the clinical trial (CT) process are presented. CT research is a complex process which includes the protocol editing, its use and implementation in the CT experimentation, and the evaluation of the results. To improve the medical research, it is necessary to consider the CT research process as a whole. We structured the CT research process in three subprocesses: a) clinical trial management; b) management of statistical units; and c) patient health care delivery process. Each process has different objectives and is enacted in different environments, carried out by its own agents and resources, and influenced by specific rules characterising each process. The model is supported by three perspectives on the CT process: functional, structural, and behavioural views. They become three distinct models in our comprehensive CT model. Descriptions of these models at a high level of abstraction are presented using the standard UML (Unified Modelling Language) version 2.0.