Optimizing drug dosing in oncology has long been a challenge. The current drug development paradigm is oriented toward identifying a maximum tolerated dose (MTD) in early-stage trials, and evaluating the MTD for drug activity and efficacy in Phase II and III trials. In recent years, the limitations of this approach have become clearer.
In the wake of evidence that many approved oncology drugs are inadequately characterized with approved doses that may be too high, 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.
To accelerate speed to market and maximize their chances of a successful clinical trial, pharmaceutical and biopharma companies will need to embrace the Project Optimus paradigm of comprehensive dose characterization. They will require the ability to perform patient-specific and population-level drug response simulations in real time, within clinical trials. Companies must be able to characterize each drug’s pharmacokinetics and pharmacodynamics, and to predict dose-specific adverse events and clinical response. Implementing new dose selection and optimization strategies for each phase of a clinical trial will help pharma companies determine dosing that maximizes efficacy, safety, and tolerability—and ultimately, the usability of their products.
Read the full article on Applied Clinical Trials at:
https://www.appliedclinicaltrialsonline.com/view/understanding-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.