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