Clinical Trials Arena March 6, 2025
Project Optimus seeks to transform how doses are selected and optimised in oncology drug development. As this initiative grows, the need for diverse data insights will affect clinical trial timelines and costs. Can advanced diagnostics help identify the right dose based on a patient’s molecular profile, pharmacodynamics, and tumour biology?
In 2021, the Project Optimus initiative was launched by the US Food and Drug Administration’s (FDA) Oncology Center of Excellence, with the aim of reforming the dose selection paradigm in oncology drug development[i]. The goal was to address concerns with the traditional Maximum Tolerated Dose (MTD) approach to dose selection, which may lead to insufficiently characterised doses and schedules for molecularly targeted therapies before pivotal trials commence.
According to the...
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