STATISTICAL METHODS FOR CLINICAL TRIALS

该项目的总体目标仍然是开发和 研究有效设计和分析的方法， 临床研究。 一个主要的具体目标将是制定适当的方法， 对于III期癌症临床试验，特别是多组III期 审判我们将继续研究适用于订购的统计数据， 替代品，并将开发适合以下情况的设计： 可以假设备选方案具有这样的顺序限制。 析因设计的实用方法，明确考虑到 互动的可能性，将得到发展。 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的 回归树方法我们还将继续研究方法， 用于多状态和多变量生存数据，从 多状态的情况下，可以概括为概率是 随着时间的推移处于给定状态（可能以活着为条件），以及 双变量生存数据进行单变量删失。扩展 将随着项目的进行探讨。 在我们的临床研究工作中出现的其他主题也将是 探讨了组序思想将扩展到问题 随着时间的推移和小样本的发展， 将研究对数秩检验的分布。 总的来说，该项目将有助于改善癌症 通过更好的设计、实施和分析方法， 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.