STATISTICAL METHODS FOR CLINICAL TRIALS

临床试验的统计方法

• 批准号: 6102663
• 负责人: JOHN J CROWLEY
• 金额: $ 18.91万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-02-11 至 1999-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6102663
• 关键词: human data; method development; neoplasm /cancer therapy; statistics /biometry

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.

该项目的总体目标继续是开发和 研究有效设计和分析的方法 临床研究。 主要目的是开发适当的方法 对于III期癌症临床试验，尤其是多臂III期 试验。我们将继续研究适合订购的统计信息 替代方案，并将开发适合情况的设计 可以认为替代方案具有这样的订单限制。 阶乘设计的实用方法，明确津贴 将开发互动的可能性。 我们还将继续从事生存的探索方法 分析，强调平滑的回归功能和扩展 回归树方法。我们还将继续研究 与多类和多元生存数据一起使用 可以通过存在的概率来概括的多态情况 随着时间的流逝，在给定的状态下（可能以活着的为条件），并且 与双变量生存数据受单变量审查。扩展 随着项目的进行，将探索。 我们在临床研究工作中出现的其他主题也将是 探索。小组顺序的想法将扩展到 随着时间的流逝，开发预后因素的击打和小样本 将研究洛格兰克测试的分布。 总体而言，该项目将有助于改善癌症 通过更好的设计，进行和分析的方法来死亡 临床研究。