Moving the needle for oncology dose optimization: A call for action.

This article explores the significance of dose optimization in the development of oncology drugs and the importance of a patient-centered approach. It discusses the efforts of scientific organizations like Friends of Cancer Research and the American Society of Clinical Oncology in addressing this issue. The article presents the findings of a survey conducted by the American Society for Clinical Pharmacology and Therapeutics on oncology dose optimization, including the use of pharmacodynamic biomarkers and different approaches for dose selection. It also discusses translational development strategies and the role of clinical pharmacology in driving progress in dose optimization. The article concludes by emphasizing the need for patient-focused dose optimization and the transformation of clinical trial paradigms in oncology. Additionally, it discusses the use of quantitative clinical pharmacology and Bayesian trial designs in optimizing dosing regimens, highlighting the importance of model-based analyses and the integration of preclinical, clinical, and biomarker data. The article also emphasizes the need for collaboration between pharmacologists and statisticians to maximize the benefits of Bayesian frameworks. It draws parallels between HIV drug discovery and oncology, highlighting the potential for biomarkers and early-stage investment to improve outcomes. The text concludes by calling for further research and discussion to advance patient-focused evidence generation in oncology therapy development. [Extracted from the article]