Optimizing the FDA’s Project Optimus: opportunities and challenges

Nature Reviews Clinical Oncology, Published online: 21 December 2023; doi:10.1038/s41571-023-00853-zThrough Project Optimus, the FDA calls for radical changes in the design of early phase trials to identify the optimal doses of oncology drugs to achieve maximal efficacy with better tolerability and patient acceptability. Herein, we discuss approaches that will enable the implementation of this initiative as well as some concerns that the draft guidance has raised in the oncology community.
Source: Nature Reviews Clinical Oncology - Category: Cancer & Oncology Authors: Source Type: research