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Activity Number:
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129
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Type:
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Invited
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Date/Time:
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Monday, August 12, 2002 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section*
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| Abstract - #300082 |
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Title:
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Practical Mid-Course Sample Size Modification In Clinical Trials
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Author(s):
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Mike Proschan*+ and Qing Liu and Sally Hunsberger
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Affiliation(s):
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National Heart Lung and Blood Institute and R.W. Johnson Pharmaceutical Research Institute and National Cancer Institute
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Address:
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6701 Rockledge Dr., Rm. 8222, MSC 7938, Bethesda , Maryland, 20892-7938,
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Keywords:
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Two-stage design ; Conditional error function
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Abstract:
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Power calculations are very important in the planning of a well-designed clinical trial. Sometimes there is limited information available before the trial, making it highly desirable to adjust the sample size after seeing actual trial data. We point out the difficulty in accurately estimating the treatment effect midway through a trial, and we encourage the use of a simple, conservative approach whereby sample size can be increased, but not decreased, from what was originally planned. We show how to compute the p-value and confidence interval for this two-stage procedure. If the original sample size is maintained, analysis of the data is the same as for a fixed-sample procedure.
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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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