Synthetic control arms Infographic

Single arm trials are emerging as an accepted way of assessing a new treatment intervention. They
establish clinical benefit by demonstrating the positive effects of a new therapy or treatment, without the need to use placebo or standard of care as a control. Instead, alternative approaches of establishing the comparison are used; these have become known as external controls or synthetic control arms (SCA) and include approaches leveraging real world data from various sources or evaluations of historical clinical trial data. In several cases, synthetic controls can prove to be quite helpful and they can resolve difficult problems in a fairly short period of time.