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Title
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Design, Monitoring, and Analysis of Group Sequential Clinical Trials
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Date / Time / Room
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Sponsor
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Type
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08/12/2002
8:15 AM -
4:15 PM
Room: H-Clinton Suite
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ASA, Biometrics Section*
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Other
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Organizer:
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n/a
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Chair:
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n/a
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CE Presenter
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- University of Washington
- University of Washington
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Description
Increasing, clinical trials are conducted using group sequential methods in order to address the ethical and efficiency issues that arise when performing experiments with human volunteers. The design, conduct, and analysis of a sequential clinical trial is necessarily more involved than that for a clinical trial in which the data would only be analyzed at the end of the study. In this one day short course I present the additional issues that must be considered when designing, monitoring, and reporting the results of a group sequential trial.
The morning session will be a qualitative presentation of the issues that arise in the conduct of clinical trials, especially as it pertains to the monitoring of such trials. The intended audience is researchers who want to understand the basic principles that should be used to assess whether the monitoring plan for a particular clinical trial is appropriate. No knowledge of statistics is presumed.
The afternoon session will be more quantitative presentation of the statistical design of clinical trials. The intended audience is researchers active in designing clinical trials or in evaluating the statistical operating characteristics of such designs. Knowledge of hypothesis testing and clinical trial design for comparing means or binomial proportions is nonsequential studies is presumed.
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