A new data-driven approach is gaining traction in clinical development: synthetic control arms that use external datasets to generate comparator groups. The innovation spotlight described how synthetic or external control arm generation can reduce dependence on placebo groups, potentially addressing recruitment and ethical constraints in trials. The report highlights Qureight’s strategy for repeated random sampling from external datasets and the use of imaging biomarkers to support more efficient study designs—citing idiopathic pulmonary fibrosis as a key example where conventional trial structures can be hard to power.