Abstract #301569

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JSM 2002 Abstract #301569
Activity Number: 317
Type: Contributed
Date/Time: Wednesday, August 14, 2002 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section*
Abstract - #301569
Title: The Use of Historical Control Information for Trend Test in Carcinogenesis
Author(s): Man Tang*+ and Jianhua Guo
Affiliation(s): Harvard University and Yale University
Address: Brigham and Women's Hospital, Harvard Medical Scho, Boston, Massachusetts, 02115, USA
Keywords: Beta-binomial distribution ; Historical controls ; Level probability ; Trend test
Abstract:

We propose a new non-model-based significance test for detecting dose-response relationship with the incorporation of historical control data. This non-model-based test is considered simpler from a regulatory perspective because it does not require to validate any modeling assumptions. Moreover, this test is especially appropriate to those studies in which the intravenous doses for the investigational chemical are labeled as, for instance, low, medium and high, or the dose labels do not suggest any obvious choices of dose scores. More importantly, this test can be easily adopted for detecting general dose-response shape such as umbrella pattern. We illustrate our method with two data sets from carcinogenesis studies. The performance of the proposed test and the famous model-based Tarone's trend test with respect to size and power will be discussed as well.

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Revised March 2002