JSM 2004 - Toronto

Abstract #301108

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Activity Number: 437
Type: Contributed
Date/Time: Thursday, August 12, 2004 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #301108
Title: A Compatible Nonparametric Estimate of Placebo Effect after Estimating the Shift in Multicenter Clinical Trials
Author(s): Mushfiqur Rashid*+
Companies: U.S. Food and Drug Administration
Address: CDER, Division of Biometrics 2, 5600 Fishers Lane, Rockville, MD, 20857,
Keywords: r-estimate ; placebo effect ; shift ; rank test
Abstract:

In clinical trials, usually the shift (between treatment difference) is estimated by Hodges-Lehmann estimate based on Mann-Whitney and Wilcoxon test. But the placebo effect (or control effect) is usually estimated by the median of the data from the placebo (control group) group and the drug effect is estimated by median of the data from drug group. However, the difference of these two medians is not equal to estimate of the shift (using on Mann-Whitney and Wilcoxon test). One could use the difference between the two medians to estimate the shift. However, the standard shift estimate (using on Mann-Whitney and Wilcoxon test) will be more efficient than the estimate based on the difference of placebo median and drug median. Compatible nonparametric estimates of placebo effect, drug effect, and shift will be developed in a multicenter trial setting.

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