卓越中心
医学
食品药品监督管理局
卓越
医学物理学
地铁列车时刻表
临床试验
药品
药物开发
肿瘤科
重症监护医学
风险分析(工程)
药理学
计算机科学
内科学
数据库
政治学
法学
操作系统
作者
Peter F. Thall,Elizabeth Garrett‐Mayer,Nolan A Wages,Susan Halabi,Ying Kuen Cheung
标识
DOI:10.1177/17407745241234652
摘要
With the advent of targeted agents and immunological therapies, the medical research community has become increasingly aware that conventional methods for determining the best dose or schedule of a new agent are inadequate. It has been well established that conventional phase I designs cannot reliably identify safe and effective doses. This problem applies, generally, for cytotoxic agents, radiation therapy, targeted agents, and immunotherapies. To address this, the US Food and Drug Administration's Oncology Center of Excellence initiated Project Optimus, with the goal "to reform the dose optimization and dose selection paradigm in oncology drug development." As a response to Project Optimus, the articles in this special issue of Clinical Trials review recent advances in methods for choosing the dose or schedule of a new agent with an overall objective of informing clinical trialists of these innovative designs. This introductory article briefly reviews problems with conventional methods, the regulatory changes that encourage better dose optimization designs, and provides brief summaries of the articles that follow in this special issue.
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