Designing Clinical Trials to Demonstrate Superiority Over Robust Standards of Care to Breakthrough the Plateau
Time: 1:30 pm
day: Day One Track 2 PM
Details:
- Explore alternative endpoints to reveal incremental benefits when standard clinical markers indicate limited room for progress, such as using patient-reported outcomes or advanced biomarkers to capture subtler treatment effects
- Evaluate novel trial designs like adaptive trials or crossover studies that allow flexibility in assessing superiority over the standard of care, potentially enhancing statistical power and improving study efficiency
- Discuss patient population stratification strategies to identify subgroups more likely to benefit from novel interventions, allowing for a targeted approach that highlights areas where standard treatments may not address specific needs fully