This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 256
Type: Contributed
Date/Time: Monday, August 2, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #308922
Title: The Use of Contrast-Enhancing Lesions to Predict Imminent Relapse: Validating Cutter's Rule
Author(s): Charity Johanna Morgan*+ and Ashutosh Ranjan and Gary Cutter
Companies: The University of Alabama at Birmingham and The University of Alabama at Birmingham and University of Alabama at Birmingham
Address: RPHB 443, Birmingham, AL, 35294-0022,
Keywords: Multiple Sclerosis ; Clinical Trials ; Safety Rules

The number of new contrast-enhancing lesions discovered via MRI is a well-established outcome variable for multiple sclerosis clinical trials. Recent research suggests that a sharp increase in lesion count may be a marker of increased risk of relapse. Accordingly, a number of studies have used contrast-enhancing lesions as a marker of safety. Cutter's rule is one such safety monitoring tool. Cutter's rule recommends that subjects exhibiting a significant number of lesions over the baseline level be referred for closer monitoring. The rule has been used in many trials, but its performance has been unpublished due to the unavailability of raw data with which to assess its efficacy. We analyzed data from a recent clinical trial for the purpose of evaluating the performance of Cutter's rule. We develop the theoretical rationale for the rule and demonstrate its performance in this trial.

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