Archives: Agenda

• Understanding the biological mechanisms that drive treatment resistance in oncology
• Using biomarkers to identify patients most likely to benefit from targeted therapies
• Applying functional genomics to uncover new therapeutic targets and resistance pathways

• Limitations in translational models, and implementing designs to succeed in trial
• Balancing the risk and reward for patients to attain key endpoints while building the exploratory
• Adaptive trial designs to accommodate changes in treatment paradigms

• Alternative data sources have the potential to strengthen clinical evaluation
• AI-assisted RECIST workflows can automate lesion identification and measurement along with human oversight
• Use of algorithmic approaches with RWD such as real-world Lugano may strengthen the bridge between clinical trials and RWE

Key Takeaways:

• Understand what oncology site networks are telling sponsors and CROs about enrollment, engagement and retention in early phase trials
• Learn why putting site needs and operational realities at the forefront of trial design improves execution and patient experience
• See how practical, site‑first operational design decisions can accelerate start‑up and improve overall trial performance