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Activity Number: 245
Type: Contributed
Date/Time: Monday, July 30, 2012 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #305573
Title: Estimating the Effect Size of Approved Drugs for the Treatment of Bacterial Conjunctivitis Studies
Author(s): Yan Wang*+ and Yunfan Deng and Daphne Lin and Jennifer Harris
Companies: FDA/CDER/OTS/OB and FDA/CDER/OTS/OB and FDA and FDA/CDER/OND/OAP/DTOP
Address: 10809 Warfield Pl, Columbia, MD, 21044, United States
Keywords: Effect Size ; Non-inferiority Margin ; Non-inferiority Trial
Abstract:

By examining the study designs and outcomes of the past clinical trials for the treatment of bacterial conjunctivitis, we present our findings on the treatment effect sizes of the approved drugs since 2000. Our findings demonstrate how the treatment effect sizes are affected by study design factors such as the definition of the efficacy endpoint, the assessment time point for the efficacy endpoint, the treatment dosing frequency/duration, and the analysis dataset. Our findings shed light on the appropriateness of the NI margins used in the past non-inferiority trials, and address the issue whether conducting a NI trial with an approved drug as a comparator is justifiable and/or feasible.


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