SDACTFATopicalAntimicrobialCoalition.pptVIP

March 23, 2005 3/23/2005 SDA/CTFA Topical Antimicrobial Coalition Presentation to FDA Nonprescription Drugs Advisory Committee March 23, 2005 AGENDA The Value of Surrogate Endpoint Testing, G. Fischler Statistical Issues in Study Design, J. Bowman Questions The Value of Surrogate Endpoint Testing for Topical Antimicrobial Products George Fischler The Dial Corporation Overview Clinical trials Standardized test methodology Surrogate endpoints Larson, E. 1995. APIC Guideline for Handwashing and Hand Antisepsis in Health Care Settings.  “Although a definitive, double blind, clinical trial of the effects of handwashing with an antiseptic product on nosocomial infection rates may be infeasible, it appears that, at least in certain high risk situations, such antimicrobial products are beneficial.” Clinical Trial Issues for Prophylactic Indications Size Ethics Immunological host status Mode of transmission Intended beneficiary Test subject vs. population Compliance Key Point Standardized, defined and peer reviewed test methodologies ensure reliability, reproducibility and comparability of test results FDA, 1978 TFM “..the reduction of the normal flora, both transient and resident, has been sufficiently supported to be considered a benefit. The only determination that remains therefore, is how much of a reduction in microbial flora will be required to permit claims for the various product classes.” Fischler G.E., et al. 2002. The Effect of Modification to the ASTM E1174 Healthcare Personnel Handwash Method on the Evaluation of Antimicrobial Effectiveness Three methods Current ASTM Pre 1994 ASTM (NDA) 1994 TFM Comparison of methods Inoculum application Neutralization Timing of baseline enumeration Fischler G.E., et al. 2002. The Effect of Modification to the ASTM E1174 Healthcare Personnel Handwash Method on the Evaluation of Antimicrobial Effectiveness Sickbert-Bennett E. E., et al. 2004. The Effects of Test Variables on the Efficacy of Hand Hygiene Agents Healthc