Single-Arm Clinical Trial

Single-Arm Clinical Trial

China: Key Considerations in Using Real-World Evidence to Support Drug Development – A non-randomized clinical trial where only the experimental group is set up. A single-arm trial, usually uses external controls based on historical data or in a parallel manner (as per Key Considerations in Using Real-World Evidence to Support Drug Development (Draft for Public Review) – Center for Drug Evaluation, NMPA – May, 2019)