Single-arm clinical trials—in which all enrolled patients receive active treatment and no one receives placebo control—have long been acceptable to regulatory authorities in those instances in which inclusion of a control arm is either infeasible or unethical. These situations arise particularly in rare diseases and oncology. In the wake of the 21st Century Cures Act, FDA has shown increased amenability to use of real-world data sources to identify patients for synthetic control arms in single-arm clinical trials.
This free webinar will describe the fundamentals of synthetic control arms with a focus on oncology trials, highlighting when they are done, why they are done, and how they are done. The featured speakers will frame the issues and articulate the common approaches to synthetic control arms in a manner that balances strategic aspects of research design with methodologic rigor on operationalizing the approach.