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Abstract #21842 Published in IGR 10-3
Predictive value of the efficacy of glaucoma medications in regulatory trials: Phase I-III to post-marketing studies
Stewart WC; Jenkins JNEye 2008; 22: 985-988
PURPOSE: To determine the predictive value of early Phase trials (I-II) for the ocular hypotensive efficacy observed in Phases III and IV.DesignA review of published literature. METHODS: This study evaluated 12 medicines in 65 articles in the literature with at least two phases available. RESULTS: For medicines with Phase I results available (n = 3), the average reduction in intraocular pressure (IOP) from untreated baseline was 16%, 26% for Phase II, 26% for Phase III, and 24% for Phase IV. For medicines with Phase II results available (n = 6), the average reduction in IOP was 23%, 24% for Phase III, and 23% for Phase IV. For medicines with Phase III results available (n = 11), the average reduction in IOP was 25% and 24% for Phase IV. CONCLUSIONS: This study indicates that early phase trials usually approximated the results of later regulatory studies and post-commercialization trials.
Dr. W.C. Stewart, Pharmaceutical Research Network, LLC, Dallas, TX, USA
Classification:
11.14 Investigational drugs; pharmacological experiments (Part of: 11 Medical treatment)
