David Cameron

<p>The FDA's Project FrontRunner is a transformative initiative aimed at accelerating the development of oncology therapies by shifting the focus to earlier lines of treatment. This blog post delves into the broader context of FDA initiatives, such as Project Optimus and Project FrontRunner, and their impact on early-phase oncology trials.</p> <h4>How can FDA Initiatives be incorporated into Early-Phase Trial Design?</h4> <p>Emerging FDA initiatives, such as Project Optimus for dose optimization guidance and Project FrontRunner for guidance on seeking earlier approvals for oncology therapies, play a crucial role in shaping early clinical trial strategies. These initiatives encourage a more structured approach to determining the right dose and selecting the best patient population to evaluate earlier in the treatment continuum.</p> <p>A common starting point in early-phase oncology development is dose escalation. While the traditional 3+3 design is still seen, more sponsors are turning to Bayesian Optimal Inte