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