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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.


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