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Sample size tables for exact single-stage phase II designs.

¹Department of Computing and Information, Royal Marsden NHS Trust, Fulham Road, London SW3 6JJ, UK.

Statistics in Medicine

|March 17, 2001

Summary

Exact binomial distribution tables offer superior accuracy for single-phase II trials compared to Fleming

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Area of Science:

Biostatistics
Clinical Trial Design

Background:

Phase II clinical trials are crucial for evaluating treatment efficacy.
Existing methods like Fleming's design rely on normal approximations, which can be imprecise.

Purpose of the Study:

To present accurate statistical tables for single-phase II trials.
To highlight the advantages of using the exact binomial distribution over normal approximations.

Main Methods:

Development of exact binomial distribution-based tables for trial analysis.
Comparison with tables derived from Fleming's normal approximation design.

Main Results:

Exact binomial tables provide more reliable results for phase II trials.
Fleming's design can yield anomalous outcomes, including acceptance of unfavorable success rates.

Conclusions:

The exact binomial distribution is recommended for phase II trial design and analysis.
Utilizing exact methods enhances the precision and validity of clinical trial results.

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