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Keyword Search Criteria: medical device returned 6 record(s)
Sunday, 07/29/2018
Application of Propensity Score Quintile Matching for Baseline Parameters in a Medical Device Trial Design
Hong Wang, Boston Scientific Corporation; Songtao Jiang, Boston Scientific; Peter Lam, Boston Scientific
2:05 PM

Leveraging Existing Information in Medical Device Clinical Trials
Rajesh Nair, CDRH/FDA; Xuefeng Li, CDRH/FDA; Laura Thompson, CDRH/FDA
3:05 PM

Monday, 07/30/2018
A Propensity Score Stratified Bayesian Power Prior Approach for Incorporating Real-World Evidence in Single Group Medical Device Clinical Studies
Chenguang Wang, John Hopkins University; Ram Tiwari, Center for Devices and Radiologica Health, FDA; Lilly Yue, U.S. Food and Drug Administration; Yunling Xu, FDA/CDRH
10:55 AM

Tuesday, 07/31/2018
Response to Regulatory Issues in an Adaptive Medical Device Study
Jill Stankowski, ICON Plc


Wednesday, 08/01/2018
Successful Implementation of Bayesian Adaptive Designs in Medical Device Clinical Studies
Zengri Wang


Opportunities of Using Real World Data to Inform Regulatory Considerations for Medical Devices
Martin Ho, FDA
2:25 PM