JSM 2004 - Toronto

Abstract #300463

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Activity Number: 338
Type: Contributed
Date/Time: Wednesday, August 11, 2004 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #300463
Title: Setting Tolerance Limits in Clinical Trials with Dichotomous Outcomes
Author(s): Boris G. Zaslavsky*+
Companies: U.S. Food and Drug Administration
Address: 1401 Rockville Pike HFM-219, Rockville, MD, 20852,
Keywords: clinical trial ; confidence ; tolerance ; StatXact ; binomial distribution ; negative binomial distribution
Abstract:

Statistical evaluation and planning of clinical trials frequently utilizes the notion of confidence intervals. The definition of confidence intervals is well known and is broadly accepted by biomedical researchers. In some clinical trials the notion of tolerance interval is utilized. This notion is applicable to the clinical trials that evaluate products based on their performance in a part of the population. The tolerance intervals are rarely mentioned in clinical protocols, even though they are used often in some clinical studies. When the outcomes of a trial are continuous, the tolerance intervals are used in validation and process control of medical products. Tolerance intervals for normally distributed variables can be calculated using available statistical tables. For dichotomous outcomes, the definition of a tolerance interval is complicated, and no tables are available to calculate it. This research provides an algorithm for calculating tolerance intervals using StatXact.

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Revised March 2004