Tag: phase 1

Clinical Research: Phase 1 - Phase 4

Phase 1 Trials: Strategies for Site Selection and Dose-Escalation

Introduction 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...

Clinical Research: Phase 1 - Phase 4

5 Key Takeaways: Insights on Alternative Designs to the Traditional 3+3 Design in Phase 1 Dose Escalation Studies

Traditionally, Phase 1 trials commonly utilize 3+3 designs to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Studies have shown, however, that two out of three trials employing a 3+3 design failed in identifying the MTD, and better approaches are needed.1 During Premier Research’s recent webinar Alternative Designs to the...