|
Activity Number:
|
94
|
|
Type:
|
Topic Contributed
|
|
Date/Time:
|
Monday, July 30, 2007 : 8:30 AM to 10:20 AM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #309763 |
|
Title:
|
Modeling Longitudinal Count Data with Possibility of Dropouts
|
|
Author(s):
|
Mohamed Alosh*+
|
|
Companies:
|
Food and Drug Administration
|
|
Address:
|
Mail stop 5319 Building 22, Silver Spring, MD, 20993,
|
|
Keywords:
|
longitudinal count data ; dropouts
|
|
Abstract:
|
The primary endpoint for many clinical trials is counts, which frequently used to reflect the severity of the disease. Examples of this include the number of lesions in dermatologic indications such as acne, basal-cell carcinoma or actinic keratosis or the number of daily seizers in epilepsy trials. For such trials the primary endpoint is usually evaluated at successive intervals during the course of the trial. One of the features of such trials is heterogeneity among subjects in their baseline counts and/or change in their expected counts during of the course of the trial. Dropouts in such trials might be related to the severity of the disease as expressed in counts. We consider random effect approach for modeling such data along with their dropouts.
|
