Handwashing: Are Experimental Models a Substitute for Clinical Trials? Two Viewpoints

Abstract

CLINICAL RELEVANCE OF EXPERIMENTAL MODELS FOR TESTING EFFICACY OF TOPICAL ANTIMICROBIAL PRODUCTS Elaine Larson, PhD, RN, FAAN, CIC The need for standardized test methodologies for the evaluation of topical antimicrobial products has been formally recognized in the United States by the Food and Drug Administration (FDA), by a Committee for Standardization of Disinfectants in Europe and, subsequently, the Council of Europe. Brief histories of their activities are summarized by Bruch and Larson1 and by Ayliffe.2 Most test programs include in vitro evaluation to measure minimum inhibitory concentrations (MIC) of the active ingredient against a battery of standard test organisms as a screening mechanism to demonstrate antimicrobial activity. However, a myriad of variations exist with regard to other aspects of testing. Some of the variations in test methodology can be explained on the basis of why products are being tested. Indications for use of a product, the frequency and intensity of its use and the desired effect(s) are criteria an investigator considers in