GROUP SEQUENTIAL METHODS FOR CLINICAL TRIALS

临床试验的分组序贯方法

• 批准号: 2095326
• 负责人: Scott S Emerson
• 金额: $ 8.65万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-01-01 至 1995-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2095326
• 关键词: clinical trials; computer program /software; statistics /biometry

Interim analyses are often performed in clinical trials to allow early termination of the study as soon as the investigators can be confident of the results. Such interim analyses better address the ethical and efficiency concerns inherent in a large scale clinical trial. The goal of this research is to broaden the spectrum of studies in which interim analyses can be used and to facilitate the use of such designs. Specific areas of research include: 1) development of methods to adjust survival curves for bias introduced by interim analyses; 2) investigation of methods to allow more flexible determination of number and timing of analyses; 3) specification of group sequential test designs appropriate for analysis of variance; 4) development of estimation methods for use in sequential analysis of variance; 5) investigation into the robustness of group sequential methods to departures from standard assumptions; and 6) development of computer software to integrate new and existing group sequential methods into a statistical analysis package.

临床试验中经常进行中期分析，以便尽早进行 一旦研究人员确信可以终止研究 结果。此类临时分析更好地解决了道德和 大规模临床试验固有的效率问题。目标是 这项研究旨在拓宽研究范围，其中临时 可以使用分析并促进此类设计的使用。具体的 研究领域包括：1）开发调整生存的方法 中期分析引入的偏差曲线； 2）方法考察 允许更灵活地确定分析的数量和时间安排； 3） 适用于分析的组序贯测试设计规范 方差; 4) 开发连续使用的估计方法 方差分析； 5）群体稳健性考察 偏离标准假设的顺序方法；和 6) 开发计算机软件以整合新的和现有的团队 将顺序方法整合到统计分析包中。