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Abstract Details
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Activity Number:
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131
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Type:
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Contributed
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Date/Time:
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Monday, August 1, 2011 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301182 |
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Title:
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Noninferiority Margin for Longitudinal Data: The Timolol Ophthalmic Solution Example
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Author(s):
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Rima Izem*+
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Companies:
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U.S. Food and Drug Administration/CDER
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Address:
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, Silver Spring, MD, 20993, US
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Keywords:
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Non-inferiority ;
longitudinal data ;
ophthalmic drug
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Abstract:
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In this presentation we share our derivation of an ophthalmic drug's non-inferiority margin for a longitudinal primary endpoint using limited historical data. In addition to the derivation, we briefly discuss non-inferiority design and testing strategies for longitudinal endpoints assessing both the short term treatment effect and the long term maintenance of treatment effect. We use the example of Timolol Ophthalmic solution 0.5% twice a day (TIM) for the indication of lowering elevated intra-ocular pressure in subjects with open angle glaucoma or ocular hypertension. TIM is one of the recommended and the most used active control comparator in Phase 3 trials for this indication. Deriving a non-inferiority margin for TIM is difficult because there is limited longitudinal data comparing TIM to placebo. We show how to account for diurnal variation and effect of the drug over time in our non-inferiority derivation.
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