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CC = Colorado Convention Center   H = Hyatt Regency Denver at Colorado Convention Center
* = applied session       ! = JSM meeting theme

Activity Details

605 * ! Thu, 8/1/2019, 8:30 AM - 10:20 AM CC-603
Innovations in Use of Historical Control Data in Clinical Trials — Topic Contributed Papers
Biopharmaceutical Section, Section on Medical Devices and Diagnostics, Biometrics Section, Section on Statistical Consulting, Statistics and Pharmacometrics Interest Group
Organizer(s): Steven Schwager, Cornell University
Chair(s): Steven Schwager, Cornell University
8:35 AM Exploring External Controls Using Prior Clinical Trial Data

Pallavi Mishra-Kalyani, US Food and Drug Administration
8:55 AM Composite Likelihood Approach for Incorporating the Entropy Balance Weighting of Real World Data (RWD) in Uncontrolled and Randomized-Controlled Trials (RCTs)
Guanglei Yu, Eli Lilly and Company; Margaret Gamalo-Siebers, Eli Lilly; Yuanyuan Bian, Eli Lilly and Company
9:15 AM Incorporation of Historical Information in Pediatric Trials

James Travis, FDA
9:35 AM Real World Data for Oncology Drug Development: Promise and Pitfalls

Catherine Tuglus, Amgen; Qui Tran, Amgen; Chris Holland, Immunocore
9:55 AM Strengthening Clinical Trials Through Synthetic Control Arms
Antara Majumdar, Medidata Solutions; Ruthie Davi, Medidata Solutions; Steven Schwager, Medidata Solutions
10:15 AM Floor Discussion