Celsion, a mid-sized biopharmaceutical company, needed to assess the efficacy of their new compound, GEN-1. Although the treatment showed impressive progression-free survival (PFS) in a Phase Ib trial, the study was single-arm. That is, it did not have a control arm to compare against the PFS estimate. Celsion could not estimate the comparative efficacy in GEN-1 with their trial data alone, leaving them unsure whether to continue drug development. 

Download this case study to see how Medidata AI helped this sponsor with:

• Compose a Synthetic Control Arm of historic clinical trial patients that were near-perfect matches for the characteristics of the GEN-1 Phase Ib patients
• Gain a better understanding of treatment effects and justify a subsequent Phase II clinical trial
• Plan a subsequent Phase II clinical trial with approximately 20 fewer patients than was previously estimated, reducing clinical trial cost and accelerating drug development timelines