Defining endpoints and measuring clinical benefits in advanced therapies

Establishing the right endpoints is critical to evaluating efficacy, safety, and translational success in advanced therapies. This spotlight session outlines approaches to align endpoints with biomarker strategies, dose selection, and patient variability, ensuring reliable and actionable clinical insights.

Key takeaways

• Identify clinical endpoints that accurately reflect therapeutic impact and translational fidelity
• Integrate biomarker strategies to support early clinical decision making
• Define frameworks for assessing clinical benefit across diverse patient populations
• Align endpoint selection with dose escalation and safety margin considerations
• Apply analytic methods that enhance predictive validity and data interpretability