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

Abstract Details

Activity Number: 129
Type: Contributed
Date/Time: Monday, August 2, 2010 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #308211
Title: Variability Exploration in Six Phase III Diabetes Clinical Trials: Implications for Research Studies
Author(s): Hua Guo*+ and Bret Musser
Companies: Merck Research Laboratories and Merck Research Laboratories
Address: 126 East Lincoln Avenue, Rahway, NJ, 07065, USA
Keywords: variability ; clinical trial design ; baseline factors ; sample size ; K nearest neighbor
Abstract:

Understanding the variability of the primary endpoint for a clinical study is important in designing and monitoring a clinical study. Based on the results of previously conducted studies, the impact of key baseline factors on variability can be explored. We propose two approaches to assess the impact of study duration, age, gender, race, and other baseline values on endpoint variability. First, a graphical approach using K nearest neighbors is used to visual the effects. Second, a statistical modeling approach is used to identify influential factors on the variability. A statistical model based on linear mixed models is proposed to quantify the relationship between identified influential factors and the variance of primary endpoint.

An application of the proposed techniques will be presented.


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