Considerations for Study Designs Incorporating External Data Sources to Augment or Generate Control Arm

2:00 PM - 3:30 PM, Tuesday, June 4, 2019 ・ 118A, Level 100
Ability to store, merge and analyze large volumes of data allows to introduce efficiencies into drug development. For example, one area of focus is to build external control arms. A number of companies and other stakeholders have been exploring how data from completed Clinical Trials or Real World Data (RWD) could augment or replace control arms in clinical trials of new drugs. Panelists will share their insights on methods for generating external control arms with data derived from either completed clinical trials or RWD, and start to establish best practices for incorporating these control into clinical trials.
Global Head of Real World Data, Oncology
VP and the Head of Quantitative Sciences
Flatiron Health
Project Datasphere
President & Chief Science Officer
Aetion, Inc.
Lead Mathematical Statistician
U.S. Food and Drug Administration