White Paper
Leveraging Synthetic Control Arms in Clinical Trials and RWE Studies
Feb 18, 2025
Clinical trials are constantly evolving, especially in the context of rare or serious drug indications where uncontrolled trials are common. These trials often use single-arm designs, which can introduce bias due to the lack of randomization. To mitigate this, sponsors may use Synthetic Control Arms (SCAs), which utilize patient-level data from external sources to enhance trial interpretation and support product development. SCAs have become a valuable tool in clinical research, offering cost reduction and faster results by leveraging real-world data. This white paper discusses the principles, benefits, and challenges of SCAs, particularly in real-world evidence studies.

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