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

White Paper

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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Although Randomized Control Trials (RCTs) play a vital role in assessing the safety and efficacy of new treatments, sometimes it is not possible to maintain a concurrent control arm.

Thankfully, External Control Arms (ECAs) can provide a solution, enabling sponsors to address recruitment challenges in trials and offering additional data to improve trial results.

In this eBook, you will learn about:
• The growing importance of ECAs
• The differences between control groups built with real world data (RWD) and a Synthetic Control Arm (SCA®) leveraging historical clinical trial data (HCTD)
• How SCA impacts clinical trial design decisions

Read on to uncover the compelling benefits of ECAs.

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

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

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