Reusing Clinical Protocol Content to Improve R&D Productivity
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Reusing Clinical Protocol Content to Improve R&D Productivity
Fredric J. Cohen, MD Medidata Solutions Worldwide Inc. Conshohocken, Pennsylvania
Key Words Content reuse; Extensible protocol: Knowledge transfer: Productivity Correspondence Address Frednc J . Cohen, Pharma Growth Strategies, LLC. 13 Summit Center Square, Suite 132, Lunghome, PA 19047 (email: [email protected]). Presented at the 21st Annual DIA Conference for Electronic Data Management, February 2008, Philadelphia, Pennsylvania.
Protocols are insttudional 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. ~er+ow, the clinical protocol may be viewed as centmlly located in a clinical research knowledge network, whose nodes represent study personnel and their means of conveying k n d kdge, and whose linkages r&esen; Gowledge transfer among personnel. Document-centric practices have limited the efficiencyof clinical
THE C L I N I C A L 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-
knowledge transfer by discoumging computerassisted content reuse. In orderfor computersto facilitate content reuse, some content must be structured and semantically modded. Becaarse of its dominant network centrality the structuredprotocd environmentis id& situated to become the primary conveyancefor new howledge about planned and in-progress studies (ie, the study metadata). Enterprise-scale computer-facilitated reuse of protocd-sourred content is predicted to have near-immediatem d e benefits on study conduct quality and opemtional efficiency
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 efficien
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