Legend: CC = Colorado Convention Center H = Hyatt Regency Denver at Colorado Convention Center
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
