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Activity Number:
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91
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Type:
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Other
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Date/Time:
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Monday, August 9, 2004 : 10:30 AM to 12:20 PM
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Sponsor:
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ASA
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| Abstract - #301990 |
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Title:
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Clinical Trials, Medical Ethics, and Statistical Reasoning
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Author(s):
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Pranab K. Sen*+
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Companies:
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University of North Carolina, Chapel Hill
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Address:
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Depts. of Biostatistics and Statistics, Chapel Hill, NC, 27599-0001,
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Keywords:
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Abstract:
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The Helsinki 1997 declaration by the World Medical Association has generated a number of practical issues connected with the conduct of clinical trials, especially in the third-world countries, where, in addition to debatable medical ethics (for using human subjects under discretionary environment), the affordability as well as cost-benefit issues are of primary concern. The conventional Placebo-Controlled Trials (PCT), for which statistical resolutions have been in the offing since 1970s, need a critical appraisal, and Activity-Controlled Equivalence Trials (ACET) have been advocated. This change in scenario signals a number of statistical issues that need to be addressed in the light of practical adaptability as well as methodologic support. Some of these issues are appraised in the light of time-sequential nonparametrics (TSN), and the needed modifications of the otherwise existing methodology are discussed in detail. The issue of incorporating interim analysis schemes is a vital part of this appraisal.
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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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