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Activity Number:
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377
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Type:
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Contributed
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Date/Time:
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Wednesday, August 1, 2007 : 8:30 AM to 10:20 AM
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Sponsor:
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Biometrics Section
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| Abstract - #308533 |
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Title:
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On Identifying Minimum Efficacious Doses in Combination Drug Trials
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Author(s):
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Julia Soulakova*+ and Allan Sampson
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Companies:
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University of Nebraska-Lincoln and University of Pittsburgh
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Address:
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340 Hardin Hall North, Lincoln, NE, 68583-0963,
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Keywords:
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Average test ; Closed testing ; Dose response ; Minimum effective dose ; Step-down procedure
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Abstract:
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In the combination drug case with at least one component known to be effective at the considered doses, the FDA regulatory requirements can be satisfied by showing that the combination is superior to each component. We term such a combination efficacious. The problem is to identify the minimum efficacious combinations, which is important especially when administering higher doses of the drug can cause serious side effects. We propose a testing procedure based on the "average" test under the closed testing principle. This procedure is shown to have strong control of overall error. The simulation studies are used to assess the performance in terms of power, lack of power and family-wise error. Among non-empty minimum efficacious dose sets the quality of the procedure improves with increasing global gain average and the procedure performs the best when the set contains the highest dose.
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