9 Tips For Designing And Operationalizing Early-Stage Precision Oncology Studies

By Abie Ekangaki

Early-stage clinical trials tend to focus on toxicity assessment and dose selection, requiring careful planning in study design and execution. More recently, the life sciences industry has observed an increase in Phase 1/2a trials being designed to draw inference about preliminary response rates. These designs changes are, in part, due to the use of biomarkers and adaptive design approaches that enhance the early detection of efficacy signals.

These approaches have the potential to make studies more complex, and as a result, will require careful planning from study design to execution.

Explore these nine tips to improve design and operations in critical elements of precision oncology studies.