JSM 2017 Online Program

Legend:
CC = Baltimore Convention Center, H = Hilton Baltimore
* = applied session ! = JSM meeting theme

Keyword Search Criteria: Non-inferiority returned 12 record(s)

Monday, 07/31/2017

Non-Inferiority Trials for Efficacy and Safety
Steve Snapinn, Amgen

SYSTEMATIC REVIEW of MISSING DATA HANDLING in NON-INFERIORITY TRIALS
Brooke Rabe, University of Arizona; Mallorie Fiero, U.S. Food and Drug Administration; Melanie Bell, University of Arizona

Statistical Considerations of Adhesion Data Analysis in NDA
Yu-Ting Weng, FDA; Caroline Strasinger, FDA; Meiyu Shen, C DER, FDA

Tuesday, 08/01/2017

Use of Historical Information via Bayesian Approach in Non-Inferiority Trial: With Application in Mental Health
Samiran Ghosh, Wayne State University - Detroit, MI; Santu Ghosh, Augusta University
10:55 AM

Wednesday, 08/02/2017

Implementing Multiple Imputation in Non-Inferiority Clinical Trials
Brian Wiens, Tobira Therapeutics; Ilya Lipkovich, QuintilesIMS
12:05 PM

Bayesian Approach of Assessing Non-Inferiority of a New Treatment with Binary Outcomes in a Three-Arm Trial
Shrabanti Chowdhury; Samiran Ghosh, Wayne State University - Detroit, MI; Ram Tiwari, FDA/CDER/OT/OB
2:05 PM

A Simple Mantel-Haenszel Type Test for Non-Inferiority
Kallappa Koti
2:20 PM

Ratio of Means vs. Difference of Means Non-Inferiority or Equivalence Tests -Difference in Adjustment for Covariates
Wanjie Sun, FDA; Stella Grosser, FDA
2:35 PM

Non-Inferiority Trial Design by Considering Maximally/Minimally Observed Treatment Difference
Shufang Liu, Astellas Pharma; Misun Lee, Astellas Pharma
2:50 PM

Use of Historical Control Data in the Analysis of a Non-Inferiority Trial
Isaac Nuamah, Janssen R & D; Youping Huang, Janssen R&D; Yevgen Tymofyeyev, Janssen R&D
3:05 PM

Immunogenicity Study Design for Biosimilar Approval
Junshan Qiu, FDA; Mike Mikailov, FDA; Ram Tiwari, FDA/CDER/OT/OB
3:35 PM

Thursday, 08/03/2017

Multiple Testing Approaches in Device Clinical Trials
Vandana Mukhi, FDA/CDRH; Heng Li, U. S. FDA
9:20 AM