...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Controlled clinical trials >Design and analysis of two-period studies of potentially disease-modifying treatments.
【24h】

Design and analysis of two-period studies of potentially disease-modifying treatments.

机译：设计和分析两个时期的潜在疾病缓解疗法研究。

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

A number of two-period designs have been introduced in the neurological clinical trials literature to evaluate the effects of treatment on progressive diseases, using names such as withdrawal, active-extension, randomized withdrawal, randomized start, and staggered-start designs. After parallel groups complete the first period, treatment is either initiated or withdrawn in the second period in a subset of subjects. The purpose of the second period is to provide evidence of whether any effect of treatment observed during the first period is long-term ("disease-modifying") or short-term and transitory ("symptomatic"). A four-arm version, which we term a complete two-period design, has active/active, active/placebo, placebo/active and placebo/placebo respective treatment assignments in the two periods. We provide statistical models for these designs, describe some of the appropriate analyses, and investigate the relative efficiencies of various allocations and special cases. We describe extensions to fulland partial factorial versions of such designs which permit efficient and simultaneous evaluation of disease-modifying and symptomatic effects of two or more treatments, along with possible interactions. Advantages and limitations of the various designs are discussed.
机译：在神经病学临床试验文献中已经引入了许多两个时期的设计，以评估治疗对进行性疾病的效果，使用诸如停药，主动扩展，随机停药，随机开始和交错开始设计等名称。平行组完成第一个阶段后，在第二个阶段中对部分受试者开始治疗或中止治疗。第二个阶段的目的是提供证据，证明在第一个阶段观察到的任何治疗效果是长期的（“改变疾病”）还是短期的和短暂的（“有症状的”）。四臂版本，我们称其为完整的两期设计，在两个时期内分别进行了主动/主动，主动/安慰剂，安慰剂/主动和安慰剂/安慰剂治疗。我们为这些设计提供统计模型，描述一些适​​当的分析，并研究各种分配和特殊情况的相对效率。我们描述了这种设计的全部和部分析因版本的扩展，这些扩展允许高效，同时评估两种或多种治疗方法对疾病缓解和症状的影响以及可能的相互作用。讨论了各种设计的优点和局限性。

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