The MORPHEUS Phase Ib/II trial explores a transformative approach in clinical research by integrating real-world data (RWD) as a hybrid control arm to supplement traditional randomized controlled trials (RCTs) in pancreatic ductal adenocarcinoma (PDAC).
This study highlights the feasibility of leveraging electronic health records to construct external control arms, addressing challenges such as patient recruitment and control arm randomization. The hybrid control approach not only maintained the integrity of clinical outcomes but also improved the precision of trial results, demonstrating comparable overall survival outcomes between experimental treatments and hybrid control groups.
Key findings include the use of advanced analytical models like Bayesian dynamic borrowing and Cox proportional hazards, which provided robust, consistent results. This method showcases the potential to optimize trial designs, enhance patient participation, and expedite the development of effective therapies.
The MORPHEUS trial sets a precedent for future research, emphasizing the critical role of RWD in modern oncology studies and its capability to support decision-making in early drug development programs.
