Roundtable: Integrating Patient-Reported Tolerability in Early Phase Oncology Trials

Session details:

This roundtable will discuss the growing push to integrate patient-reported tolerability in early phase oncology trials, where adverse events are often underreported or filtered through investigator interpretation. Participants will discuss:

• How to embed PRT in early-phase oncology design and execution

• Training investigators, coordinators, and patients for consistent PRT use and data quality

• Tools and approaches for capturing tolerability in early phase trials

• Addressing the gaps between investigator-reported vs. patient-reported tolerability data

• Developing a robust data management plan covering data capture, analytics, and early patient withdrawal handling

• How early patient-reported data can influence dose selection, labeling, and development decisions

• Barriers to adoption, including lack of standardization and operational complexity