Synthetic control arms leverage real world data from various sources or evaluations of historical clinical data to demonstrate the positive effects of a new therapy or treatment, without the need to use a placebo or standard of care as a control.
Regulators in both the United States and Europe have responded positively to the use of SCAs in clinical development. While implementation of this method for regulatory purposes might be a new development, the majority of statistical and mathematical theories used for the design of SCAs are decades old and familiar to the scientific community. However, synthetic control arm studies are often subject to many misplaced industry myths.
During this webinar our panel of expert speakers from Cytel, Roche and CIOX Health, will share their insights and bust Real-World Data industry myths around the use of synthetic controls in research and regulatory applications. In addition, they will dispel and bust a number of myths related to their specific sector of industry, namely pharma, data vendor, and consulting.