Optimizing Precision Medicine Strategies Before the Trial Begins

Precision medicine strategies can improve the ability to identify patients most likely to benefit from treatment, but selecting the right biomarker strategy and trial design can be challenging.

In this case, a biotechnology company developing a treatment for a chronic disease was planning a Phase 2b study with a novel biomarker strategy. The original study design had an estimated 20% probability of success, creating significant uncertainty around the likelihood of demonstrating a meaningful treatment effect.

MMS used KerusCloud® simulation to prospectively evaluate alternative biomarker-driven trial designs and identify strategies that could improve the probability of study success without increasing sample size or cost.

Key Benefits

• Learn how simulation can optimize precision medicine strategies before a clinical trial begins.
• See how biomarker assumptions can influence clinical trial probability of success.
• Understand how alternative patient-selection strategies can be evaluated quantitatively.
• Discover how simulation can identify opportunities to improve study success without increasing sample size.
• Learn how KerusCloud® can support evidence-based precision medicine trial design.
• See how prospective modeling can help sponsors reduce clinical development uncertainty.