Dose Optimization Studies: Sample Size, Speed, and Strength

Music City Center 

In recent years, dose optimization has emerged as a crucial element in the development of oncology drugs, with regulatory authorities increasingly mandating comprehensive data and justification for dosing before Phase 3 trials. Despite this, the practical implementation of optimization studies, especially in terms of design, remains a complex challenge. This presentation will delve into the intricacies of planning these studies, focusing on strategies for selecting appropriate sample sizes, evaluating alternative study designs, and making informed dose selection decisions.