STATISTICAL METHODS FOR CLINICAL TRIALS

这个项目的总体目标仍然是发展和 高效设计与分析方法的研究 临床研究。 一个主要的具体目标将是开发适当的方法 第三期癌症临床试验，特别是多臂第三期 审判。我们将继续编制适用于Order的统计数据 替代方案，并将开发适合以下情况的设计 可以假设替代方案具有这样的订单限制。 析因设计的实用方法，明确考虑 相互作用的可能性，将被开发。 我们还将继续探索生存方法的工作。 分析，强调平滑回归函数和扩展 回归树方法。我们还将继续研究方法，以 使用多状态和多变量生存数据，以 可以用存在的概率来概括的多态情况 随着时间的推移处于给定状态(可能以活着为条件)，以及 双变量生存数据服从单变量删失。延拓 将随着项目的进行而进行探索。 我们在临床研究工作中出现的其他主题也将是 探索过了。群体顺序思想将被推广到以下问题 随着时间的推移，形成了一系列预后因素，而且样本很小 将调查LOGRANK测试的分布情况。 作为一个整体，该项目将有助于癌症的改善 通过更好的设计、实施和分析方法来降低死亡率 临床研究。

The overall goal of this project continues to be the development and investigation of methods for the efficient design and analysis of clinical studies. A major specific aim will be on the development of methods appropriate for phase III cancer clinical trials, especially multi-arm phase III trials. We will continue to work on statistics appropriate for ordered alternatives, and will develop designs appropriate for situations when the alternatives can be assumed to have such an order restriction. Practical approaches for factorial designs, making explicit allowance for the possibility of interactions, will be developed. We will also continue our work in exploratory methods for survival analysis, emphasizing smoothed regression functions and extensions of the regression tree methodology. We will also continue to work on methods for use with multistate and multivariate survival data, starting with multistate situations which can be summarized by the probability of being in a given state over time (possibly conditional on being alive), and with bivariate survival data subject to univariate censoring. Extensions will be explored as the project proceeds. Other topics that arise in our work on clinical studies will also be explored. Group sequential ideas will be extended to the problem of developing a batted of prognostic factors over time, and small sample distributions for the logrank test will be investigated. Taken as a whole, the project will contribute to improvements in cancer mortality through better methods for design, conduct and analysis of clinical studies.