Clinical Trials Arena May 2, 2024
Experts say that Project Optimus is a necessary reform in the oncology space, but one that should be applied with caution.
Alongside the multitude of guidance documents, recent years have seen the US Food and Drug Administration (FDA) ramp up workshops and project implementation efforts in a bid to drive innovation in drug development. Agency eyes have zeroed in on oncology, with the FDA Oncology Center of Excellence (OCE) introducing frameworks such as Project Optimus to reform the dose optimisation and dose selection paradigm in oncology drug development.
While the framework of Optimus is not new to drug development, it is relatively new to oncology. In non-deadly indications, researchers have been employing the framework for quite some time because the...
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