Optimizing the FDA’s Project Optimus: opportunities and challenges
- Resource Type
- Brief Communication
- Authors
- Rodney, Simon; Banerji, Udai
- Source
- Nature Reviews Clinical Oncology. 21(3):165-166
- Subject
- Language
- English
- ISSN
- 1759-4774
1759-4782
Through 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Herein, we discuss approaches that will enable the implementation of this initiative as well as some concerns that the draft guidance has raised in the oncology community.