Cancer prevalence is rising globally, and tackling this complex issue requires comprehensive and proactive measures.
Traditional approaches to choosing therapy dose, often based on cytotoxic chemotherapy, may result in doses being too high or too low, causing unnecessary toxicity levels or not providing enough benefit to patients.
Project Optimus, introduced by the FDA’s Oncology Center of Excellence, aims to change the current dose optimisation and dose selection paradigm in oncology drug development.
However, implementing this initiative and improving patient outcomes is not without its challenges, including the complexity of clinical trial design and management and lack of clear guidance.
Read our recent blog to find out more about Project Optimus and learn how we can help you prepare for its implementation.