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Synthetic Control Arm®: The Regulatory Grade External Control Arm to Power your Clinical Trials

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Synthetic Control Arm®: The Regulatory Grade External Control Arm to Power your Clinical Trials

By Medidata

Synthetic Control Arm®: The Regulatory Grade External Control Arm to Power your Clinical Trials

By Medidata
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Randomized Control Trials (RCTs) are the gold standard for evaluating the safety and efficacy of new treatments. However, in some circumstances, maintaining a concurrent control arm is not feasible.

External Control Arms (ECAs) can help sponsors overcome recruitment challenges in trials with small patient populations. They can also provide supplementary data, beyond what a clinical trial itself can produce, to bolster trial results when necessary.

This eBook provides guidance on the increasing role of ECAs, the differences between control groups built using real world data (RWD) and a Synthetic Control Arm (SCA® ) containing historical clinical trial data (HCTD), and the successful impact of SCA on clinical trial design decisions and regulatory conversations.

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