...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Statistical methods in medical research >Two-stage phase II oncology designs using short-term endpoints for early stopping
【24h】

Two-stage phase II oncology designs using short-term endpoints for early stopping

机译：双阶段第二期肿瘤学设计使用短期终点进行早期停止

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Phase II oncology trials are conducted to evaluate whether the tumour activity of a new treatment is promising enough to warrant further investigation. The most commonly used approach in this context is a two-stage single-arm design with binary endpoint. As for all designs with interim analysis, its efficiency strongly depends on the relation between recruitment rate and follow-up time required to measure the patients' outcomes. Usually, recruitment is postponed after the sample size of the first stage is achieved up until the outcomes of all patients are available. This may lead to a considerable increase of the trial length and with it to a delay in the drug development process. We propose a design where an intermediate endpoint is used in the interim analysis to decide whether or not the study is continued with a second stage. Optimal and minimax versions of this design are derived. The characteristics of the proposed design in terms of type I error rate, power, maximum and expected sample size as well as trial duration are investigated. Guidance is given on how to select the most appropriate design. Application is illustrated by a phase II oncology trial in patients with advanced angiosarcoma, which motivated this research.
机译：进行期间肿瘤学试验以评估新治疗的肿瘤活性是否足以提供进一步调查。在此上下文中最常用的方法是具有二进制端点的两级单臂设计。至于临时分析的所有设计，其效率强烈取决于招聘率与衡量患者结果所需的后续时间之间的关系。通常，在达到第一阶段的样本量之前推迟招聘，直到所有患者的结果都有。这可能导致试验长度的大幅增加，并延迟了药物开发过程。我们提出了一种设计，其中中间端点用于临时分析，以决定该研究是否继续进行第二阶段。派生了这种设计的最佳和最低限度版本。研究了I型错误率，功率，最大值和预期样本大小以及试验持续时间方面所提出的设计的特性。有关如何选择最合适的设计的指导。申请通过先进的昂贵arcoma患者的II期肿瘤学试验说明，这激发了这项研究。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号