Phase 1 Trials: Strategies For Site Selection And Dose-Escalation

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.

Also, selecting appropriate sites and choosing an adequate dose-escalation design for early-phase oncology trials can help sponsors adhere to projected timelines, limit the number of patients exposed to ineffective doses, and accelerate the process of identifying a Phase 2 dose. By partnering with a contract research organization with deep experience in early-phase oncology trials, sponsors may be able to more easily navigate the unique regulatory environment to bring safe, effective therapies to cancer patients more quickly.

This white paper explores key considerations for site selection and dose-escalation design strategies in early-phase oncology trials. Insight is also provided into how to navigate regulatory and statistical challenges to keep these trials moving forward as quickly and safely as possible.