JSM 2005 - Toronto

Abstract #304639

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 230
Type: Contributed
Date/Time: Tuesday, August 9, 2005 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #304639
Title: Use of Inverse Bionomial Sampling in Exact Test of Relative Risk for Rare Events in Clinical Trials
Author(s): Xinwei D. Jia*+ and Dar Shong Hwang
Companies: Forest Research Institute and B.R.S.I.
Address: Harborside Financial Center, Jersey City, NJ, 07311, United States
Keywords: Relative Risk ; Odds Ratio ; Exact Test ; Binomial Distribution ; Inverse Binomial Distribution ; Inverse Binomial Sampling
Abstract:

Clinical studies dealing with ever-smaller event rates are common. The inference procedures are typically based on a binomial model. The study itself is regarded for each group as a fixed number of Bernoulli trials with a probability (p) for a specified event (e.g., responder, disease progression). In the literature, statistical inference usually is conducted for a transformed metric called Odds (p/(1-p)). Odds Ratio is taken for the comparison of two independent samples/groups. Often, the ratio of the probabilities for the specified event between two independent groups in the study, p1/p2, is intrinsically more interesting. In this paper, we will explore an alternative distribution model and its sampling method, namely, Inverse Binomial Distribution (IBN) and Inverse Binomial Sampling (IBS), in conducting exact statistical test directly for p1/p2 (relative risk). We developed an alternative testing procedure and discuss scenarios in clinical trials where IBS may be utilized. We focus on events with small probabilities. Exact test and confidence interval for relative risk are discussed.

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