The FDA has taken a clear position with Project Optimus in shifting toward more progressive tailored approaches while rejecting antiquated study designs to evolve clinical trial strategies to better align with newer drug classes.
The FDA released its draft guidance in support of Project Optimus in January 2023. It offers clear direction for industry stakeholders to unlock efficiencies in oncology drug and biologic development. The FDA’s draft guidance also underscores the benefits patient-centric approaches can have on quality of life, medication adherence, and long-term clinical outcomes.
With Project Optimus, the FDA has taken a clear position. It solidifies the shift away from traditional chemotherapy and toward more progressive tailored approaches. It rejects antiquated study designs and offers a relevant primer on how to evolve clinical trial strategies to better align with newer drug classes.
The baton has now been passed to the life sciences industry to harness its resources to drive efficiencies in process and enable a patient-first mindset. AI arguably is the most essential tool at our disposal for unlocking those efficiencies and reaping the benefits of breakthrough science. It's up to us as stewards to ensure that the right drugs now reach the right patients at the right dose.
Read the full article at Applied Clinical Trials: https://www.appliedclinicaltrialsonline.com/view/artificial-intelligence-drives-industry-response-to-project-optimus
Sirj Goswami, PhD, is the CEO and co-founder, and Jason Rizzo, MBA, is the vice president of Global Biopharma Strategy for InsightRX.
