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Sessions Were Renumbered as of May 19.

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CC-W = McCormick Place Convention Center, West Building,   CC-N = McCormick Place Convention Center, North Building
H = Hilton Chicago,   UC= Conference Chicago at University Center
* = applied session       ! = JSM meeting theme

Keyword Search Criteria: Interim returned 18 record(s)
Monday, 08/01/2016
Best Practices for Interim Analysis in Clinical Trials
Jiang Hu, FDA


A Simulation Method Based on Interim Results to Assess Conditional Power in Clinical Trials
Lin Pan, ICON PLC; Jill Stankowski, ICON PLC; Joseph M. Massaro, Boston University


Graphical Testing Procedure in a Hypothetical Seamless Phase II/III Oncology Study
Jiacheng Yuan, Bayer HealthCare Pharmaceuticals; Jonathan Siegel, Bayer HealthCare Pharmaceuticals; Daniel Haverstock, Bayer HealthCare Pharmaceuticals
8:35 AM

Risk Analysis on Using Surrogate Endpoint at Interim Analysis
Ziqian Geng, AbbVie; Bo Fu, AbbVie; Alan Hartford, AbbVie; Jun Zhao, AbbVie
10:05 AM

A Phase 2a Bayesian Adaptive Dose-Ranging Trial Evaluating Hypertension Therapy
Richann Liu, Pfizer
2:05 PM

Tuesday, 08/02/2016
Interim Futility Analysis in the Presence of Delayed Effect in Immunotherapy Clinical Trials
Xue Lin


An Application of the Adaptive Bayesian Design for the Delayed Outcomes in a Phase II Clinical Trial
Lei Feng, MD Anderson Cancer Center; Steven H. Lin, MD Anderson Cancer Center; Suyu Liu, MD Anderson Cancer Center


Innovative Bayesian Applications in Clinical Trials
Soumi Lahiri, GlaxoSmithKline; Satrajit Roychoudhury, Novartis
8:55 AM

Interim Go/No-Go Decision Making in Clinical Trials with Longitudinal Outcomes
Ming Zhou, Bristol-Myers Squibb; Qi Tang, AbbVie; Lixin Lang, Bristol-Myers Squibb; Jun Xing, Bristol-Myers Squibb; Kay Tatsuoka, Bristol-Myers Squibb
9:15 AM

Regulatory and Practical Considerations for an Adaptive Trial in the Context of Evaluating a Combination Product: An Example Using Two Human MAbs to Prevent Recurrence of CDI
Kenneth Koury, Merck Research Laboratories; Robert Tipping, Merck Research Laboratories
11:15 AM

Developing PRO Instruments in Clinical Trials: Issues, Considerations, and Solutions
Cheryl Coon, Outcometrix; Dennis Revicki, Evidera; Scott Komo, FDA/CDER; Kendra DeBusk, Genentech; Lisa Kammerman, AstraZeneca; Stacie Hudgens, Clinical Outcome Solutions
2:05 PM

Interim Timing in Adaptive Two-Stage Dose-Finding Studies: What Happens to the Expected Benefit?
Tobias Mielke, ICON PLC
2:45 PM

Wednesday, 08/03/2016
Bayesian Approach for Interim Analysis with Failure Time Endpoint
Zailong Wang, Novartis Pharma; Chen Gao, University of Minnesota; Peter Mesenbrink, Novartis Pharma
8:35 AM

Adaptive Enrichment with Subpopulation Selection at Interim
Xiang Ling, FDA/CDER; Sue-Jane Wang, FDA; Kun Jin, FDA/CDER; Hsien-Ming James Hung, FDA
9:35 AM

Arm Dropping in Clinical Trials: An In-Depth Look at Statistical Considerations and Implications
JonDavid Sparks, Eli Lilly and Company; Brian Millen, Eli Lilly and Company; Qi Zhang, Eli Lilly and Company
10:05 AM

The Three Pillars of a Successful Data Monitoring Committee Organizational Meeting and Interim Monitoring of a Randomized Clinical Trial and the Eventual Impact on Public Health
Navneet Ram Hakhu, Axio Research
10:35 AM

Enhanced Conditional Power and Predictive Power Using Auxiliary Information
Libo Sun, Janssen R&D; Ying Wan, Janssen R&D
11:05 AM

Thursday, 08/04/2016
Defensive Efficacy Interim Design: Dynamic Benefit/Risk Ratio View Using Probability of Success
Zhongwen Tang, Novartis
10:50 AM

 
 
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