Mathematics Research Seminar Series: Novel Applications of the use of Synthetic Control for Causal Estimation of Effects of Therapeutic Interventions within the Framework of Augmented-Control Designs

Mathematics Research Seminar Series
Novel Applications of the use of Synthetic Control for Causal Estimation of Effects of Therapeutic Interventions within the Framework of Augmented-Control Designs

by Margaret Gamalo, PhD
Statistics Head, Inflammation and Immunology
Pfizer

Date: Wednesday, 12 July 2023
Time: 3:30 - 5:00 pm
Venue: https://bit.ly/AdmuMathSeminar (Online)
             SEC A 303-304 (Onsite)

Abstract:
Since 2014, synthetic controls, defined as a statistical method used to evaluate the comparative effectiveness of an intervention using a weighted combination of external controls in successful regulatory submissions in rare diseases and oncology is growing. In the next few years, the utilization of synthetic controls is likely to increase within the regulatory space owing to concurrent improvements in medical record collection, statistical methodologies, and sheer demand. In this talk, I will focus on existing and new strategies from the applications of synthetic controls in the framework of augmented control designs. This will include (1) matching strategies and use of entrophy balancing; (2) distinction of causal estimands in augmented designs; (3) Bayesian methodologies for incorporating external information; (4) novel adaptive designs incorporating external information.

About the Speaker:
Margaret (Meg) Gamalo, PhD is VP, Statistics Head for Inflammation and Immunology in Pfizer Global Product Development. She combines expertise in biostatistics, regulatory science and adult and pediatric clinical development. Prior to joining Pfizer, she was Research Advisor, Global Statistical Sciences at Eli Lilly and Company and as Mathematical Statistician at the Food and Drug Administration. Meg leads the Complex Innovative Design Task Force at the Biotechnology Innovation Organization. She also actively contributes to research topics within the European Forum for Good Clinical Practice – Children’s Medicine Working Party. Meg is currently Editor-in-Chief of the Journal of Biopharmaceutical Statistics and is actively involved in many statistical activities in the American Statistical Association. Recently, she was elected Fellow of the American Statistical Association. She received her PhD in Statistics from The University of Pittsburgh.