GROUP SEQUENTIAL METHODS FOR CLINICAL TRIALS

中期分析通常在临床试验中进行，以便及早进行 一旦调查人员有信心，立即终止研究 结果。这样的中期分析更好地解决了伦理和 效率是大规模临床试验所固有的问题。的目标是 这项研究是为了拓宽研究的范围，在这些研究中 可以使用分析，以便于使用此类设计。特定的 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)方法研究 以便更灵活地确定分析的次数和时间；3) 适用于分析的成组序贯试验设计规范 方差；4)开发序贯使用的估计方法 方差分析；5)群体稳健性调查 偏离标准假设的序贯方法；和6) 开发计算机软件以整合新的和现有的小组 将序贯方法纳入统计分析包中。

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.