Conclusion The Phidisa Project research team has determined that benchmark assessments are extremely constructive and pragmatic. This
is particularly evident in a collaborative, resource-poor, multisite setting in which capacity building is a primary component
for conducting a successful clinical trial. The implementation of such tools aids in the evaluation of compliance and provides a basis for the prioritization of areas
requiring further assessment and intervention. Benchmarks allow for objective comparisons at and between sites, as well as
from one monitoring visit to the next. Most importantly, benchmark assessments can serve as a launching pad for cross-site
and leadership discussions regarding opportunities for site improvement and development of processes. Ultimately, benchmark
assessments contribute to the enhancement of clinical research compliance and strengthen site and research capacity, particularly
in resource-poor settings. AcknowledgementsThis project has been funded in whole or in part with federal funds from the National Cancer Institute and National Institutes
of Health (NIH) under contract N01-CO-12400. The content of this publication does not necessarily reflect the views or policies
of the Department of Health and Human Services, nor does mention of trade names, commercial products or organizations imply
endorsement by the U.S. Government. This research was supported in part by the National Institute of Allergy and Infectious
Diseases. Shelly Simpson* is clinical trials director, Clinical Monitoring Research Program, SAIC-Frederick, Inc., NCI-Frederick, Frederick, Maryland
21702, PO Box B, email: shsimpson@mail.nih.gov
Lorraine Africa, MS, is a member of regulatory services and Lotty Ledwaba, MD, is head of regulatory services, Phidisa Project South Africa. Anita Lessing is project manager and Siza Mphele and Jenny Thomas, RN, RM, are clinical research associates at Clindev Pty Ltd. Laura McNay is director and Judith Zuckerman, RN, BSN, CCRC, is clinical research oversight manager of the Office of Strategic Planning and Assessment, Division of Clinical
Research, National Institutes of Allergy and Infectious Diseases, National Institutes of Health. *To whom all correspondence should be addressed. References 1. http://www.doh.gov.za/search/index.html.
2. M.M. Englehart, A.J. Santicerma, J.E. Zinni, "Performance Metrics: Optimizing Outcomes," Applied Clinical Trials Supplement, October 2005, 6-9. 3. D. Babic and Iva Kucerova, "Benchmarking Clinical Trials Practices in Central and Eastern Europe," Applied Clinical Trials, May 2003, 56-58.
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