Drug Information Journal - March 2009 - (Page 131) MEDICAL INFORMATION 131 Reusing Clinical Protocol Content to Improve R&D Productivity 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 computerassisted 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. Fredric J. Cohen, MD Medidata Solutions Worldwide Inc, Conshohocken, Pennsylvania Key Words Content reuse; Extensible protocol; Knowledge transfer; Productivity Correspondence Address Fredric J. Cohen, Pharma Growth Strategies, LLC, 13 Summit Center Square, Suite 132, Langhorne, PA 19047 (email: fred@pharmagrowth.com). Presented at the 21st Annual DIA Conference for Electronic Data Management, February 2008, Philadelphia, Pennsylvania. THE CLINICAL RESEARCH KNOWLEDGE NETWORK Clinical research is essentially the creation and dissemination of knowledge. Clinical 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 (1). Every clinical study begins with a protocol, and all start-up, conduct, and reporting activities refer back to it. Therefore, contributors to the clinical protocol may be viewed as centrally located in a multiorganizational knowledge network (the clinical research knowledge network) with nodes representing study personnel and their means of conveying knowledge and linkages representing knowledge transfer (2) (Figure 1). When the research project’s work outputs are considered in light of the prerequisite knowledge permitting those activities, some basic principles underlying this knowledge network become apparent. First, knowledge transfer must be thoughtfully time-coordinated among diverse functional experts. Delays in creating, transferring, or using knowledge that is needed to begin or to com- plete an activity can have profound effects, not only on the activity itself but also on other activities that are dependent upon it. Viewed this way, knowledge management is not simply an effort to promote organizational flexibility and innovation but is also an efficiency enhancement effort, akin to other enterprise-scale endeavors that seek to measure and improve organizational business processes, such as enterprise resource planning (3,4). Second, if the centrality of protocol-sourced information is accepted, it follows that knowledge must be transferred between protocol authors and other internal (to the research organization) functional experts and external contributors and end users efficiently and effectively for the study to start and to run efficiently and effectively. Third, although the mechanisms of knowledge transfer and content reuse differ according to functional area and task, standard practice today is for people to formally (via long-form documents) and informally (via email threads, meetings, etc) transfer knowledge about the study and its resulting data (ie, its design, rationale, methods, etc) without intellectual support from computers. Rather, it is typical today for computers to provide the equivalent of adSubmitted for publication: March 10, 2008 Accepted for publication: July 2, 2008 Drug Information Journal, Vol. 43, pp. 131–138, 2009 • 0092-8615/2009 Printed in the USA. All rights reserved. Copyright © 2009 Drug Information Association, Inc.
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