Sponsors lose time when feasibility is superficial. Too often, Phase I trials are designed around scientific intent alone, without fully accounting for real-world site execution, patient accessibility and operational burden. The result: protocols that are technically sound but difficult to enroll, slow to execute and prone to costly mid-study adjustments. This session demonstrates how engaging experienced investigators early, before the protocol is finalized, can uncover hidden risks in eligibility criteria, procedures, endpoints and patient/site burden that drive amendments and delays.

Drawing on expertise from IQVIA and IQVIA Biotech, alongside a leading NEXT Oncology investigator, this panel of early-phase oncology and site strategy experts will break down the most common design-stage pitfalls and show how early investigator insight can reshape protocols to better balance scientific rigor with real-world execution. Through a practical, experience-led discussion, attendees will learn how small, targeted design decisions can significantly improve enrollment viability, data quality and execution confidence, increasing the probability of trial success from the outset. Because in early-phase oncology, it can be the wrong protocol, not the drug, that slows a program down.

Key Takeaways

• Identify the most common protocol “red flags” that drive avoidable amendments and execution delays in FIH oncology trials
• Explain how early investigator and site input can uncover hidden feasibility risks and improve trial design decisions
• Understand how structured early engagement enables faster, more confident execution and reduces downstream risk

For more information and to register, click here.

Panel

• Kristin Zorn, Ph.D., Senior Medical Director, Medical Strategy Lead, IQVIA Oncology Center of Excellence
• Shiraj Sen, M.D., Ph.D., Clinical Director, NEXT Oncology
• Bridget Weeks, Director of Project Management, Oncology