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Activity Number:
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367
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 9, 2006 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #307451 |
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Title:
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Implementing Bayesian Adaptive Dose-Response Finding Studies: a Clinical Perspective
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Author(s):
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Michael Krams*+
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Companies:
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Address:
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25 Dairy Hill Road, Madison, CT, 06443,
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Keywords:
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dose-response ; Bayesian ; adaptive
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Abstract:
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Some drug development programs fail due to insufficient attention to selecting dosages that optimize response. We discuss efficient approaches to designing clinical dose-response finding studies. A first step is to understand the disease by analyzing historical databases. We need to explore drug exposure-response relationships in a way that allows us to adjust our approach to dosing as trials progress, in light of initial results. We should continually reassess the choice of treatments we offer in trials so we optimize the acquisition of new information. Our trial designs have sequential termination rules that stop the trial as soon as a clear conclusion is reached (and not earlier). We may conclude that the treatment has too small an effect, or so large an effect that minimal dosage levels suffice---or that only a few specific dosage levels seem effective.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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