Key success factors and conclusions The data available from decades of benchmarking in clinical development provide clear evidence of the excessive absorption
of time and cost before marketing authorization. The goal-setting of strengthened productivity while balancing capacity is
not only legitimate but a must in view of three factors. These are the natural resource limitations, the economic pressures
on the health care market at large vis-á-vis the unmet therapeutic needs requiring innovation that remains affordable. All
players, operational departments, investigational sites, and clinical project leaders have a role in streamlining the processes
and making drug development more cost-effective. Out of the numerous performance metrics, it is advisable to select and track five to six key performance indicators at the
department or project level that will change behavior and drive performance. The right time-points for collection—whether
monthly, quarterly, annually or at the completion of tasks—are crucial. Past performance should set the stage for the new
performance metrics targets. These targets must be demanding but achievable. Outperforming on one metric target might have
a negative impact on others. Consequently, interdependencies have to be observed and acted on. Metrics should not be changed
before sufficient data supporting sensible conclusions are available. Appropriate comparisons across therapeutic areas, projects,
and countries are a prerequisite for meaningful decisions on future targets or trial programs. Joining large benchmarking
studies is advisable despite the associated cost and efforts needed to maintain them. Performance metrics systems can be valued as a change management trigger. Their costs are justified if the system provides
value in terms of shortening cycle times, improvement of efficiency, and quality. Disappointments and frustrations of measuring
clinical development productivity in the early days due to insufficient system support, duplicate records, and manual tracking
can now be avoided. With suitable software, a thorough understanding of underlying business processes, and a commitment to
continuous improvement, these challenges can be met. Implementing a performance metrics system will be of great value now and in the future. Focusing on performance indicators
that drive change and positively impact productivity while remaining in full regulatory compliance is an unwavering principle.
The sum of all efforts at all levels across companies will eventually reduce cycle times in clinical development and bring
innovation sooner and in a larger scale to those who need it most—the patients. References 1. K.I. Kaitin, "Drug Development Timelines Today and Tomorrow—The Challenge of Pharmaceutical R&D," Presented at the ECPM
(European Center of Pharmaceutical Medicine) Course, Session 1, 2 October 2001. 2. Pharmaceutical Research and Manufacturers of America (PhRMA), Pharmaceutical Industry Profile 2004, Washington, DC; PhRMA,
2004. 3. J.A. DiMasi, R.W. Hansen, H.G. Grabowski, "The Price of Innovation: New Estimates of Drug Development Costs," Journal of Health Economics, 22, 151-185 (2003). 4. Centre for Medicines Research International Ltd., "Innovation on the Wane?"; news downloaded from http://www.cmr.org/ on 9 August 2004. 5. S. Walker, "Trends in Global Drug Development," Presented at the ECPM (European Center of Pharmaceutical Medicine) Course,
Session 1, 2 October 2001. 6. D.S. Zuckerman and M. P. Cole, "Taking the Pulse of Pharma-CRO Relationships: The Searle-CRO Metrics System," Presented
at the Pharmaceutical Outsourcing Management Association Annual Meeting, April 1999. 7. R. Davie, "Building a Successful Relationship with Your Customers—A CRO Perspective," Presented at IQPC's 5th Conference
in the Clinical Trial Series, Brussels, 25 March 2004. 8. D.L. Anderson, "A Guide to Patient Recruitment. Today's Best Practices and Proven Strategies," CenterWatch, 2001. 9. T.J. Hill, "Can CROs Measure Up to Their Claims?" Scrip Magazine, 47-49 (March 2002). 10. J. Schenk and A.K. Hajos, "Better Use of Metrics within Clinical Research," Focus Session at the 11th Applied Clinical Trials European Summit, Munich, 13 May 2004.
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