Reusing Clinical Protocol Content to Improve R&D Productivity

Abstract

Protocols are instructional manuals for clinical research, describing study procedures and their rationale and serving as a guide for how study results will be interpreted and used. Every clinical study begins with a protocol, and all startup, conduct, and reporting activities refer back to it. Therefore, the clinical protocol may be viewed as centrally located in a clinical research knowledge network, whose nodes represent study personnel and their means of conveying knowledge, and whose linkages represent knowledge transfer among personnel. Document-centric practices have limited the efficiency of clinical knowledge transfer by discouraging computer-assisted content reuse. In order for computers to facilitate content reuse, some content must be structured and semantically modeled. Because of its dominant network centrality, the structured protocol environment is ideally situated to become the primary conveyance for new knowledge about planned and in-progress studies (ie, the study metadata). Enterprise-scale computer-facilitated reuse of protocol-sourced content is predicted to have near-immediate measurable benefits on study conduct quality and operational efficiency.