Synthetic Control Arm

A synthetic control arm is a group of external data used as a comparator in a clinical trial instead of a traditional control group. This data can come from historical trials, real-world data, or patient registries. Synthetic control arms are used to enhance study efficiency, reduce the number of required participants, and provide ethical benefits by potentially reducing the need for placebo control groups. This approach is particularly valuable in rare diseases or studies where control group recruitment is challenging.

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