End Of ‘Phase I’: The Case To Re-Name First-In-Human Oncology Trials

US FDA’s push to re-think oncology dosing should begin by renaming the initial human trials to de-emphasize toxicity, a National Cancer Institute official suggests.

The End
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A good first step in encouraging oncology drug developers to embrace dose optimization would be to abandon the traditional term “Phase I” studies, National Cancer Institute Division of Cancer Treatment and Diagnosis Director James Doroshow suggested during a workshop co-hosted by the US Food & Drug Administration and the American Society of Clinical Oncology on 3 May and 5 May.

The workshop is part of FDA’s Oncology Center of Excellence’s efforts (“Project Optimus”) to urge drug developers to abandon the...

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