Optimizing the FDA’s Project Optimus: opportunities and challenges

IF 81.1 1区医学 Q1 ONCOLOGY

Nature Reviews Clinical Oncology Pub Date : 2023-12-21 DOI:10.1038/s41571-023-00853-z

Simon Rodney, Udai Banerji

引用次数: 0

Abstract

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Herein, we discuss approaches that will enable the implementation of this initiative as well as some concerns that the draft guidance has raised in the oncology community.

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优化美国食品和药物管理局的 Optimus 项目：机遇与挑战

通过 Optimus 项目，FDA 呼吁彻底改变早期阶段试验的设计，以确定肿瘤药物的最佳剂量，从而在获得最大疗效的同时提高耐受性和患者接受度。在此，我们将讨论有助于实施这一计划的方法，以及指南草案在肿瘤学界引起的一些担忧。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Nature Reviews Clinical Oncology 医学-肿瘤学

CiteScore

99.40

自引率

0.40%

发文量

114

审稿时长

6-12 weeks

期刊介绍： Nature Reviews publishes clinical content authored by internationally renowned clinical academics and researchers, catering to readers in the medical sciences at postgraduate levels and beyond. Although targeted at practicing doctors, researchers, and academics within specific specialties, the aim is to ensure accessibility for readers across various medical disciplines. The journal features in-depth Reviews offering authoritative and current information, contextualizing topics within the history and development of a field. Perspectives, News & Views articles, and the Research Highlights section provide topical discussions, opinions, and filtered primary research from diverse medical journals.

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