Designing and executing an effective Phase 1 trial for a novel investigational oncology product can be challenging. Every facet of the process, from site selection and recruitment rate analysis to trial design and start-up, is interconnected. A nuanced approach is important, and early, careful planning is critical.
This white paper explores key considerations for site selection and dose-escalation design strategies in early-phase oncology trials. We provide insight into how to navigate regulatory and statistical challenges to keep these trials moving forward as quickly and safely as possible.