Over the past decade, a new trend began to emerge, changing the way that clinical trials are conducted.
Whereas placebo-controlled randomized control trials remain the gold standard, in some situations, synthetic control arms can be used instead. 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.
This ebook looks to explain common strategies for the construction of SCAs, and to give a high-level
overview of how statisticians think through challenges encountered during trial design, with the aim to help readers explore various uses of data and how these approaches can help in achieving the
goals of clinical development program.