Phase 0 clinical trials: Recommendations from the task force on methodology for the development of innovative cancer therapies
Phase 0 clinical trials: Recommendations from the task force on methodology for the development of innovative cancer therapies
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DOI：
10.1016/j.ejca.2008.10.024
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发表时间：
2009-03-01
影响因子：
8.4
通讯作者：
Giaccone, Giuseppe
中科院分区：
文献类型：
--
作者：
Kummar, Shivaani;Doroshow, James H.;Giaccone, Giuseppe
创新癌症疗法开发方法（MDICT）工作队已经成立，作为一个专家论坛，为开发创新抗癌药物，特别是靶向药物制定实用指南。该工作组最近讨论了抗癌药物开发中0期临床试验的效用、设计和应用。得出的结论是，非治疗性0期试验的作用存在争议，原因有几个，包括参与患者缺乏临床获益。然而，人们认识到，0期试验提供了在药物开发过程早期生成基本人体药代动力学和药效学数据的机会，这可能是有关药物进一步临床开发的设计和决策的主要优势。强烈建议构建“决策图”，以帮助研究者和申办者确定药物是否适合在0期试验中进行评价。爱思唯尔有限公司出版
The Methodology for the Development of Innovative Cancer Therapies (MDICT) task force has been established as an expert forum to develop practical guidance on the development of innovative anticancer agents, in particular targeted agents. The task force recently addressed the utility, design and application of Phase 0 clinical trials in anticancer drug development. It was concluded that the role of non-therapeutic Phase 0 trials is controversial for several reasons, including the lack of clinical benefit for participating patients. However, it was recognised that Phase 0 trials provide an opportunity to generate essential human pharmacokinetic and pharmacodynamic data earlier in the drug development process, which could be a major advantage in the design and decision making concerning further clinical development of an agent. Construction of a 'decision chart' was highly recommended to assist investigators and sponsors in determining whether an agent is suitable for evaluation in a Phase 0 trial. Published by Elsevier Ltd.