Abstract
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.
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References
Breitfeld, P.P., Weisburd, M., Overhage, M.M., Sledge, G., Tierney, W.M.: Pilot Study of a Point-of-use Decision Support Tool for cancer Clinical Trial Eligibility. JAMIA 6(6) (1999)
Fazi, P., Luzi, D., Ricci, F.L., Vignetti, M.: Supporting Writing and Diffusion of Clinical Trials. In: Proc. Information and Communication Technology Conf. 2001 (2001)
Fazi, P., Luzi, D., Manco, M., Ricci, F.L., Toffoli, G., Vignetti, M.: WITH: a System to Write Clinical Trials using XML and RDBMS. In: Proc. AMIA Symp. 2002, pp. 240–244 (2002)
Fazi, P., Luzi, D., Ricci, F.L., Vignetti, M.: The conceptual Basis of WITH, a Collaborative Writer System of Clinical Trials. In: Colosimo, A., Giuliani, A., Sirabella, P. (eds.) ISMDA 2002. LNCS, vol. 2526, pp. 86–97. Springer, Heidelberg (2002)
Guideline for good clinical practice (2000), Available at, http://www.eortc.be/documents
Modgil, S., Hammond, P., Wyatt, J.C., Potts, H.: Developing a Knowledge-based Tool for Authoring Clinical Trial Protocols. In: Proc. EWGLP 2000 (2000)
Pender, T.: UML Bible. John Wiley, Chichester (2003)
Rubin, D.L., Gennari, J.H., Musen, M.A.: Knowledge Representation and Tool Support for Critiquing Clinical Trial Protocols. In: Proceedings of the AMIA Symp. 2000 (2000)
Rubin, D.L., Gennari, J.H., Srinivas, S., Yuen, A., Kaizer, H., Musen, M.A., Silva, J.S.: Tool Support for Authoring Eligibility Criteria for Cancer Trials. In: Proc. AMIA Symp. 1999, pp. 369–373 (1999)
Serbanati, L.D.: Integrating Tools for Software Development. Yourdon Press Computing Series, Prentice Hall, Englewood Cliffs (1992)
Serbanati, L.D., Ricci, F.L., Luzi, D.: A New Approach for Modelling Clinical Trial Research. Working Paper WP IRPPS-CRR 3/2004 (June 2004)
Silva, J., Wittes, R.: Role of Clinical Trials Informatics in the NCI’s Cancer Informatics Infrastructure. In: Proc. AMIA Symp. 1999, pp. 950–954 (1999)
Standardizing Information Flow in Clinical Trial Protocols. Panel organizer: John Gennari (2000), Available at, http://www.amia.org/pubs/syposia/D200544.pdf
Unutzer, J., Choi, Y., Cook, I.A., Oishi, S.: Clinical Computing: a Web-based Data Management System to Improve Care for Depression in a Mulicenter Clinical Trial. Psychiatric Services (June 2002)
UML Superstructure version 2.0 (2003), Available at, http://www.omg.org/docs/ptc/03-08-02.pdf
Weng, C., Kahn, M., Gennari, J.H.: Temporal Knowledge Representation for Scheduling Tasks in Clinical Trial Protocols. In: Proc. AMIA Symp. 2002, pp. 879–883 (2002)
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Collada Ali, L., Fazi, P., Luzi, D., Ricci, F.L., Serbanati, L.D., Vignetti, M. (2004). Toward a Model of Clinical Trials. In: Barreiro, J.M., Martín-Sánchez, F., Maojo, V., Sanz, F. (eds) Biological and Medical Data Analysis. ISBMDA 2004. Lecture Notes in Computer Science, vol 3337. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-540-30547-7_31
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DOI: https://doi.org/10.1007/978-3-540-30547-7_31
Publisher Name: Springer, Berlin, Heidelberg
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