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Activity Number:
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592
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 6, 2009 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304347 |
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Title:
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Some Comments and Recommendations on Interim Data Review of Data from Medical Device Studies
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Author(s):
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Dennis W. King*+
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Companies:
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STATKING Consulting, Inc.
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Address:
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759 Wessel Drive, Fairfield, OH, 45014,
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Keywords:
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Interim Data Review ; Medical Device Studies
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Abstract:
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This paper describes guidelines for interim data review for industry sponsored clinical trials. For this paper, interim data review is defined as all types of data review during the progress of a clinical trial that do not affect the statistical design (Type I error adjustments) or statistical conduct (such as decisions to stop for futility or superiority based on hypothesis tests) of the trial. In both blinded and unblinded medical device trials, interim data review can pose serious issues for the sponsor of the trial. A discussion of sponsor risks related to interim data review is included in the paper along with recommendations for sponsor conduct of interim data review.
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