De-Risking Clinical Trial Design With Simulation
Designing multiple early-phase clinical trials as part of a broader development program can create difficult decisions around study design, patient populations, treatment effects, timelines, and resource allocation.
For a biotech developing RSV therapeutics, MMS used KerusCloud® and biostatistical expertise to evaluate alternative trial designs using evidence from the literature and completed RSV studies. Rather than optimizing each study independently, the team evaluated the program as a whole to identify the designs most likely to support successful development.
The resulting simulation evidence helped the sponsor identify key drivers of study success, optimize designs around the seasonal nature of RSV infection, and reduce the expected trial timeline from three years to one year.
Key Benefits
- How clinical trial simulation can de-risk early-phase study design.
- How simulation can evaluate alternative trial designs before studies begin.
- How integrated evidence can support development decisions across an entire program.
- How modeling can account for factors such as seasonal disease patterns and patient subgroups.
- How quantitative evidence can help reduce development timelines, risk, and cost.
- How stronger study design evidence can become an asset beyond clinical development.
