This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
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Activity Number:
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227
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 2, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #307034 |
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Title:
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Adaptive Design for Sample Size Re-estimation in a Medical Device Trial of Spinal Cord Stimulation
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Author(s):
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Nitzan Mekel-Bobrov*+
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Companies:
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Boston Scientific Corporation
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Address:
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25155 Rye Canyon Loop, Valencia, CA, 91355,
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Keywords:
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adaptive design ;
sample size ;
conditional probability ;
group sequential
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Abstract:
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Accurate sample size estimation is of crucial importance for the success of a clinical trial. While in well-established areas of clinical research data can be obtained from previous studies, newer areas suffer from large uncertainties in the parameter estimates underlying the sample size calculation. A variety of methods have been developed for sample size re-estimation based on interim analysis results. These "adaptive design" methods have been garnering increasing use in pharmaceutical studies but have yet to become established in clinical studies of medical devices. Here we present an adaptive design for sample size re-estimation that is being implemented in a new randomized controlled trial of a medical device for spinal cord stimulation.
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