Understanding Project Optimus
The FDA’s Oncology Center of Excellence has launched an initiative to reform the dose optimization and dose selection paradigm in oncology drug development. Known as Project Optimus, this initiative recommends a core change in how doses are selected during oncology clinical trials and post-approval studies.
Sirj Goswami, PhD, CEO, co-founder of InsightRX and Jason Rizzo, MBA, VP Global Biopharma Strategy discuss this topic in more detail in an article published by Applied Clinical Trials*.Click here to read the full article.
*About Applied Clinical Trials
Applied Clinical Trials magazine is a global, peer-reviewed journal whose coverage features the process of managing clinical trials at the intersection where pharmaceutical product developers meet the strictly regulated medical researchers who test their new drugs.