External Controls & Synthetic Arms: Building Credible Comparators for Regulatory-Grade RWE (2025)
External Controls & Synthetic Arms: Building Credible Comparators for Regulatory-Grade RWE (2025) Constructing External Controls and Synthetic Arms That Withstand Regulatory Scrutiny Why External Controls—and the Global Frame That Governs Them External controls and synthetic arms allow sponsors to estimate treatment effects when randomized concurrent controls are infeasible, unethical, or impractical—ultra-rare diseases, early signals in…