Through Project Optimus, the FDA calls for radical changes in the design of early phase trials to identify the optimal doses of oncology drugs to achieve maximal efficacy with better tolerability and patient acceptability. Herein, we discuss approaches that will enable the implementation of this initiative as well as some concerns that the draft guidance has raised in the oncology community.

中文翻译：

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优化 FDA 的 Optimus 项目：机遇与挑战

通过 Optimus 项目，FDA 呼吁对早期试验的设计进行彻底改变，以确定肿瘤药物的最佳剂量，以实现最大疗效、更好的耐受性和患者可接受性。在此，我们讨论了实施该倡议的方法，以及指南草案在肿瘤学界引起的一些担忧。