0 期临床试验：加速化学预防药物的开发。
Phase 0 trials: expediting the development of chemoprevention agents.
机构信息
Division of Cancer Treatment and Diagnosis, National Cancer Institute, NIH, Bethesda, MD 20892, USA.
出版信息
Cancer Prev Res (Phila). 2011 Mar;4(3):288-92. doi: 10.1158/1940-6207.CAPR-11-0013.
Abstract
Phase 0 trials are first-in-human clinical trials performed under the Exploratory IND [investigational new drug] Guidance of the U.S. Food and Drug Administration. Unlike traditional phase I trials, these studies have no therapeutic or diagnostic intent but instead aim to provide only pharmacokinetic and/or pharmacodynamic data to inform the next step in developing an agent. We discuss the role that such trials, including one reported by Reid and colleagues (beginning on page 347 in this issue of the journal), can play in expanding the number of drugs that are evaluated for chemoprevention while compressing the drug-development timeline.
摘要
阶段 0 试验是根据美国食品和药物管理局的探索性 IND（研究性新药）指导原则进行的首次人体临床试验。与传统的 I 期试验不同，这些研究没有治疗或诊断目的，而是旨在仅提供药代动力学和/或药效学数据，为开发药物的下一步提供信息。我们讨论了此类试验（包括 Reid 及其同事报告的一项试验，该试验见本期杂志第 347 页）在扩大用于化学预防的药物数量的同时压缩药物开发时间线上可以发挥的作用。
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