This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Keyword Search

Keyword Search Criteria: medical device returned 9 record(s)
Sunday, 08/01/2010
Design of Nonrandomized Medical Device Trials Based on Subclassification Using Propensity Score Quintiles
Greg Maislin, Biomedical Statistical Consulting; Donald B. Rubin, Harvard University
5:25 PM

Monday, 08/02/2010
The Promise and Challenge of Benefit: Risk Analysis for Medical Products
Richard Forshee, FDA


Adaptive Design for Sample Size Re-estimation in a Medical Device Trial of Spinal Cord Stimulation
Nitzan Mekel-Bobrov, Boston Scientific Corporation
2:05 PM

Tuesday, 08/03/2010
A Case Study of Issues with Subgroup Analysis for Medical Devices
Yao Huang, FDA/CDRH; Yunling Xu, FDA/CDRH
9:15 AM

Classification and Regression Tree Analysis as an Alternative for Multivariate Regression Modeling: An Application to Medical Device Trials
Jian Huang, Boston Scientific Corporation
9:35 AM

Applying Covariate-Adjusted, Response-Adaptive Randomization to Medical Device Studies
Thomas E. Gwise, FDA; Gene Anthony Pennello, FDA
10:55 AM

Wednesday, 08/04/2010
Combining Information Across Studies for Clinical Trials: What We Have Learned at FDA's Center for Devices and Radiological Health
Laura Thompson, FDA/CDRH
2:30 PM

Medical Device Software Safety, Validation, Verification, and Effectiveness
Carolyn Carroll, STAT TECH, Inc.
3:05 PM

Thursday, 08/05/2010
Analysis of Single-Arm Studies: Statistical Considerations of Study Site Variability from a Regulatory Perspective
Terri Kang Johnson, FDA/CDRH; Yunling Xu, FDA/CDRH
8:55 AM




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