Celsion Phase 1B Ovarian Cancer Clinical Trial Case Study
Downloadable Case Study
Celsion Phase Ib Ovarian Cancer Clinical Trial Shows Strong Progression-Free Survival Treatment Effect Using a Medidata AI Synthetic Control Arm®
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