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Further results on a multiple-testing procedure for clinical trials
Biometrics
|December 1, 1983
Summary
The O'Brien and Fleming procedure for multiple testing in clinical trials is effective for chronic diseases. While type I errors and power remain unchanged, sample size savings are reduced compared to acute disease models.
Area of Science:
- Clinical Trials
- Biostatistics
- Medical Research
Background:
- The O'Brien and Fleming procedure is a standard for multiple testing in acute disease clinical trials.
- Evaluating its applicability to chronic disease models is crucial for optimizing trial design.
Purpose of the Study:
- To assess the O'Brien and Fleming procedure's efficacy and impact on sample size in chronic disease clinical trials.
- To compare its performance against single-sample procedures.
Main Methods:
- The study evaluated the O'Brien and Fleming procedure using chronic-disease models.
- Statistical analysis focused on type I error rates, statistical power, and sample size requirements.
Main Results:
- The O'Brien and Fleming procedure is applicable to chronic disease models without modification.
- Type I errors and statistical power are comparable to single-sample procedures.
- Sample size savings are less pronounced for chronic diseases than for acute diseases.
Conclusions:
- The O'Brien and Fleming procedure is a valid statistical method for multiple testing in chronic disease clinical trials.
- Sample size reduction can be predicted based on power and the number of data inspections for specific disease models.
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