Best Practices For Operationalizing Global, Early-Phase Oncology Trials

The early-phase oncology trial landscape is entering a new era of complexity, shaped by evolving regulatory priorities like FDA’s Project Optimus and the rise of multiregional development strategies. With dose optimization now expected earlier in the process, trials are expanding and demand more sophisticated planning, global collaboration, and operational agility. Designing and executing these studies requires balancing scientific rigor with practical challenges such as patient recruitment, site activation, and adherence to diverse regulatory and ethical standards across regions.

Operational hurdles are compounded by the intricacies of cohort management, adaptive trial designs, investigational product logistics, and risk-based monitoring. Ensuring sites are equipped with the right expertise, resources, and infrastructure adds further complexity—especially when spread across multiple geographies and time zones. In this presentation, industry experts will share real-world lessons learned from managing global early-phase oncology trials. Viewers gain practical insights into overcoming the challenges of study startup and beyond while keeping the ultimate focus where it belongs: delivering safe, effective therapies to patients.