A Process-oriented methodology for modelling cancer treatment trial protocols

Abstract

Cancer-patient management in the context of a multi-center treatment trial requires following a complex detailed process involving multispecialty patient treatment as well as study-related tasks, described in free-text protocol documents. We present a process-oriented approach for modelling clinical trial treatment protocols (CTTPs) to be used for enabling applications that support protocol-based care process delivery, monitoring and analysis. This modelling approach provides an intuitive visual representation of the protocol document catering for change management, intra-center and national adaptations to the master protocol, and multi-level share-ability. The methodology can be reused in CTTPs of different cancer domains due to the similarity of the CTTPs in terms of required content.