Synthetic Control Arm eBook | Medidata AI Clinical Trial Services
Downloadable eBook
Synthetic Control Arm® : The Regulatory Grade External Control Arm to Power your Clinical Trials
The path from study design to approval is long, complex, and costly. Nine out of 10 clinical trials worldwide can’t recruit enough patients within their target timeframes.[1] External Control Arms (ECAs) can help sponsors overcome recruitment challenges in trials with small patient populations.
But not all external controls are created equal. A rigorous ECA will incorporate both RWD and HCTD, following FDA guidance and offering depth unmet by RWD alone.
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)
- The successful impact of SCA on clinical trial design decisions and regulatory conversations
[1] Clinical trials are better, faster, cheaper with big data, MIT Technology Review Insights, 2021
