Clinical Research: Phase 1 - Phase 4
9 Tips for Designing and Operationalizing Early-Stage Precision Oncology Studies
Traditionally, early-stage clinical trials focus on toxicity assessment and dose selection. Today, a growing number of Phase 1/2a trials are designed to draw inference about preliminary response rates due, in part, to the use of biomarkers and adaptive design approaches that enhance the early detection of efficacy signals. These approaches may add to study complexity...