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157 * Tue, 8/10/2021, 10:00 AM - 11:50 AM Virtual
Advances in Analytic Methods and Novel Applications of the Use of Synthetic Control for Causal Estimation of Effects of Therapeutic Interventions — Topic-Contributed Papers
Biometrics Section, ENAR, Section on Medical Devices and Diagnostics
Organizer(s): Margaret Gamalo, Pfizer
Chair(s): Chao-Kang Jason Liang, National Institute of Allergy and Infectious Diseases
10:05 AM Synthetic Control Trial Design with Enhanced Double Robust Estimate of Rx Effect
Ming Tan, Georgetown University
10:25 AM Evaluation of Diagnostic Tests for Low Prevalence Diseases with Leveraging Real-World Data
Wei-Chen Chen, FDA/CDRH; Heng Li, FDA/CDRH; Nelson Lu, FDA/CDRH; Changhong Song, FDA/CDRH; Chenguang Wang, JHU; Ram Tiwari, FDA/CDRH; Yunling Xu, CDRH/FDA; Lilly Q. Yue, FDA/CDRH
10:45 AM Innovative Adaptive Design for Confirmatory Trials: A Case Study in Pediatrics
Junjing Lin, Takeda Pharmaceuticals; Margaret Gamalo-Siebers, Pfizer Inc.; Ran Liao, Eli Lilly
11:05 AM Some Practical Issues of Augmenting Concurrent Control Data with Synthetic Control
Binbing Yu, AstraZeneca, LLC
11:25 AM Design and Analysis of Externally Controlled Trials: Regulatory Review Experience in Hematology and Oncology Drug Applications
Haiyan Chen, FDA
11:45 AM Floor Discussion