This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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386
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Type:
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Invited
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Date/Time:
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Tuesday, August 3, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Statisticians in the Pharmaceutical Industry
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Abstract - #306084 |
Title:
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Noninferiority Trial Designs for Odds Ratios and Risk Differences
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Author(s):
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Joan Hilton*+
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Companies:
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University of California, San Francisco
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Address:
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University of California at San Francisco, San Francisco, CA, 94107, USA
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Keywords:
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active-controlled trial ;
allocation ratio ;
ancillary parameter
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Abstract:
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We show that for noninferiority trials in which response rates are equal under the alternative hypothesis, the common response rate is a design parameter whose value lies between the Experimental and Control rates. Thus setting it equal to the Control rate underestimates the minimum overall sample size, N*. Given the Control rate, the margin, and type I and II errors, our algorithm finds the design value of the common response rate and the corresponding N* and optimal allocation ratio, gamma*. We find that gamma* is increasingly imbalanced as the margin increases, the direction of the imbalance depends on the scale of the margin (for odds ratio VS risk difference), and multiple values of gamma* map to N*. The last feature allows trade-offs between an optimal gamma* at N* and a preferred gamma at a larger N. Power is lost if the scale of the margin is changed between design and analysis.
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Authors who are presenting talks have a * after their name.
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