The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.
Online Program Home
Abstract Details
|
Activity Number:
|
3
|
|
Type:
|
Invited
|
|
Date/Time:
|
Sunday, July 29, 2012 : 2:00 PM to 3:50 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #303550 |
|
Title:
|
Sensible Analysis Plans for Incomplete Longitudinal Clinical Trial Data
|
|
Author(s):
|
Craig H Mallinclrodt*+
|
|
Companies:
|
Eli Lilly and Company
|
|
Address:
|
Lilly Corporate Center, Indianapolis, IN, 46285,
|
|
Keywords:
|
missing data ;
clinical trials ;
sensitivity analyses
|
|
Abstract:
|
The National Research Council was commissioned by FDA to make recommendations on the prevention and treatment of missing data in clinical trials. The Panel's report was made public in late 2010. This presentation will focus on a case study from a clinical trial in depression to illustrate a practical appraoch consistent with the Panel's recommendations for handling missing data from continuous endpoints. Specifically, the robustness of the a priori specified likelihood-based primary analysis will be assessed using a variety of MNAR analyses and an inclusive modeling multiple imputation approach, along with influence and residual diagnostics for the primary analysis. A novel method of imputing missing data for both the drug and placebo groups from the placebo group will be presented both as a likely conservative MNAR analysis and as an alternative to BOCF to assess effectiveness
|
The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
Back to the full JSM 2012 program
|
2012 JSM Online Program Home
For information, contact jsm@amstat.org or phone (888) 231-3473.
If you have questions about the Continuing Education program, please contact the Education Department.