Abstract #301283

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JSM 2003 Abstract #301283
Activity Number: 118
Type: Topic Contributed
Date/Time: Monday, August 4, 2003 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #301283
Title: On Sample Size Determination in the One-sample Case
Author(s): Ramachandramurty Ponnapalli*+
Companies: Food and Drug Administration
Address: HFZ-542, Rockville, MD, 20850-4307,
Keywords: success ; proportion ; test ; sample ; size
Abstract:

Suppose that the primary efficacy variable in a clinical trial is the proportion p of "successes." The efficacy of the drug or device is determined by comparison with a fixed value p0, which is obtained from either historical experience with a large number of patients or a quantity judged "standard" by the clinicians. The hypothesis that the experimental treatment is equivalent to or better than the control may be tested by testing H0: p < = p0-δ vs. H1: p>p0-δ, where δ is a positive quantity judged significant for the experimental treatment to be better than the control. This formulation as a one sample problem is analogous to the Blackwelder formulation of the two sample problem. Sample size formulas are derived by the desirable criterion of equating the power at p=p0 to a prescribed 1-ß. A similar formula is derived when the effectiveness criterion is the mean of a continuous variable.

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