Abstract Details
Activity Number:
|
355
|
Type:
|
Contributed
|
Date/Time:
|
Tuesday, August 6, 2013 : 10:30 AM to 12:20 PM
|
Sponsor:
|
Biopharmaceutical Section
|
Abstract - #309258 |
Title:
|
A Ranking Procedure of Significance Among Combined Noninferiority Studies Using Liapounov's Central Limit Theorem (LCLT)
|
Author(s):
|
Jagannath Ghosh*+ and Mohamed Mubasher
|
Companies:
|
PROUnlimited at Novartis and Research and Scientific Publications Center
|
Keywords:
|
Meta analysis ;
Non-inferiority ;
Combined study ;
Liapounov's Central Limit Theorem (LCLT)
|
Abstract:
|
Introduction: In efficacy/safety evaluations of different therapeutic/diagnostic modalities/products for the SAME clinical condition, a meta-analysis-like approach is undertaken to combine data from several studies. The purpose is to determine the most significant study that favors one modality over the rest. Real situations exist in industry when various iterations of the same product undergo several comparative studies to identify the most one. Objectives: To develop methodological approach to rank the significance of combined non-inferiority studies in determining efficacy/safety. Methods: 100,000 simulations in SAS (version 9.2) are used to create real situation of 4 control-compared studies, each representing one iteration of the therapeutic/diagnostic modality/product. LCLT is then applied to create relative weights in determining the rank of the significance of each of the combined studies. Results and conclusions: LCLT was very efficient and accurate in ranking "significant-wise" the 4 studies and hence allowed selection of the most significant study.
|
Authors who are presenting talks have a * after their name.
Back to the full JSM 2013 program
|
2013 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.
The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.
Copyright © American Statistical Association.