Synthetic Control Arms in Clinical Trials and Regulatory Applications

Overview

As an increasing number of rare diseases and disease subsets become tractable to novel therapies, there is growing pressure to increase the efficiency and effectiveness of clinical trials. One such approach is the use of real-world evidence, such as synthetic control arms. Instead of recruiting patients who have been assigned to the control arm, a synthetic control arm can repurpose historical clinical trial or real-world data to accurately match patients. This methodology has far-ranging applications in trial design, replacement/augmentation of control groups and identifying differentiation in treatment effects across subpopulations. 

This webinar discusses the methodology and applicability of synthetic control arms, especially those utilizing large clinical trial datasets, in biopharma R&D. Examples where synthetic controls have successfully been used in FDA applications are also discussed, and the emerging regulatory framework.

About the Presenter

Arnaub Chatterjee is Senior Vice President of Product and Ecosystem at Medidata Solutions, a global provider of cloud-based and analytic solutions in life sciences. In addition, he teaches courses in health policy and big data, respectively, at Harvard Medical School and Cornell University.

Prior to joining Medidata, Arnaub was Associate Partner at McKinsey & Company and primarily worked with pharma as well as large technology companies on their healthcare strategy.  Before his time at McKinsey, he worked at the pharmaceutical company Merck, serving as Director of the Data Science and Insights group and also served in the Obama Administration as an advisor to the U.S. Department of Health and Human Services.  He began his career as a strategy consultant at Deloitte Consulting.  Arnaub is a member of the Global Future Council of Biotechnology of the World Economic Forum and serves on the board of the College of Human Ecology at Cornell University.  He holds graduate degrees in health administration (MHA) from the Sloan Program and public administration (MPA) from CIPA and received his undergraduate degree from the University of Michigan.