Medidata’s white paper introduces the Synthetic Control Arm® (SCA®)—a type of external control created using patient-level data from historical clinical trials or real-world data. SCAs enable more accurate interpretation of single-arm trials by mimicking randomized controls through statistical matching. Benefits include faster trials, reduced patient exposure to placebo, improved recruitment, and regulatory support—especially in rare diseases or when traditional control arms are unfeasible. Validated case studies in lung cancer, multiple myeloma, and ovarian cancer show SCAs can replicate randomized trial results, enhance trial design, and accelerate approval timelines.

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