A well-designed clinical trial can make or break a promising therapy. This session will explore how trial design choices, endpoints, patient selection, and statistical power, have influenced past outcomes.

• Endpoints & Study Duration: Were phase 2 trials too short or underpowered to detect meaningful effects? Did reliance on FVC as the primary endpoint contribute to misleading signals?
• Patient Selection & Inclusion Criteria: Did we include the right patient populations, or was disease heterogeneity overlooked? Were exclusion criteria too broad or too restrictive?
• Statistical Pitfalls & Misleading Readouts: How often have positive phase 2 results been driven by outliers? Could alternative trial designs, such as adaptive approaches, improve decision-making?