The two discussed the future of the FDA, including potential changes during the next administration and their impact on FDA and regulatory processes. On the topic of drug pricing, Dr. Califf not ed the importance of aligning pricing with demonstrated clinical benefit. Califf highlighted the need for pragmatic trials to make healthcare more responsive and efficient.
He expressed hope for greater efforts to address public health crises, particularly reform on tobacco and food, to counteract chronic health issues and improve life expectancy. Read the Session 1 White Paper here. Geoff Oxnard of Eli Lilly and Company opened the first panel session with a presentation highlighting the complexities of interpreting interim overall survival OS data.
Using trial examples, he illustrated how crossover, treatment sequencing, and other trial design elements can impact interim OS results and complicate interpretation alongside meaningful improvements in intermediate endpoints such as progression-free survival PFS and disease-free survival DFS.
Oxnard proposed several potential solutions, including use of quality of life QoL metrics to provide additional context for evaluating the risk-benefit balance of a regimen when interim OS data are inconclusive.
Gormley noted how advancements in therapies have led to significant improvements in OS for some cancer types, prompting a shift towards using intermediate endpoints for regulatory decision-making, with interim OS providing safety information. The panelists discussed key considerations when interpreting conflicting endpoint results, especially when outcomes like response rate or PFS suggest benefit and interim OS data suggests potential harm. Panelists proposed multiple strategies and methodologies for clinical trial design and interim OS data analyses, focusing on predictive modeling, treatment switching methodologies, tipping point analysis, and managing crossover in studies.
