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Activity Number:
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472
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Type:
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Contributed
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Date/Time:
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Wednesday, August 9, 2006 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #306376 |
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Title:
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A Statistical Framework for Quantile Equivalence Clinical Trials with Application to Pharmacokinetic Studies That Bridge from HIV-Infected Adults to Children
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Author(s):
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Lixia Pei*+ and Michael Hughes
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Companies:
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Harvard University and Harvard University
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Address:
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Department of Biostatistics, HSPH, Boston, MA, 02120,
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Keywords:
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bridging clinical trials ; children ; equivalence ; HIV ; pharmacokinetic ; quantile
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Abstract:
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Many bridging trials are designed to evaluate whether a proposed dose for one population gives similar pharmacokinetic (PK) levels as an established dose in another population. For HIV bridging trials, because of the risk of viral resistance, the goal is often to determine whether the doses used in two populations result in similar percent of patients with low PK levels. For example, it may be desired to confirm that a proposed pediatric dose gives approximately 10% of children with PK levels below the 10th percentile of PK levels for the established adult dose. However, the 10th percentile for adults is often imprecisely estimated in small studies. Little attention has been given to such bridging studies. In this paper, a formal framework for the design and analysis of quantile-based bridging studies is proposed, and is used to illustrate some limitations of current trial designs.
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