Statistical Methods for Cancer Clinical Trials

癌症临床试验的统计方法

• 批准号: 8054880
• 负责人: MARIE DAVIDIAN
• 金额: $ 221.47万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-04-01 至 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8054880
• 关键词: Statistical; Methods; Cancer; Clinical; Trials

DESCRIPTION (provided by applicant): The overall scientific goal of this ambitious program project is to develop highly innovative methods for cancer clinical trials that can hasten successful introduction of effective new therapies into practice. The method of approach is to leverage recent advances in statistical and computational science to create new clinical trial designs and data analysis tools that resolve many of the key scientific limitations of current clinical trial methodology. The projects focus on practical design and analysis problems in Phase II and Phase 111 clinical trials, the problem of missing data and efficient use of prognostic information, postmarketing surveillance and comparative effectiveness research using clinical trial data, pharmacogenetics and individualized therapies, and the potential of dynamic treatment regimens to improve cancer treatment. The proposed clinical trial design and analysis innovations have the potential to change the prevailing clinical trial paradigm and greatly increase the rate of discovery and translation of new treatments into clinical practice. Our multi-institutional approach includes an effective and energetic process for intense, coordinated implementation, communication and dissemination of results, including developing new software for practical implementation of the newly developed methods. Our comprehensive and novel approach will lead to significant improvements in cancer clinical trial practice that will result in improved health of cancer patients.

描述(由申请人提供)：这一雄心勃勃的计划项目的总体科学目标是为癌症临床试验开发高度创新的方法，以加速将有效的新疗法成功地引入实践。方法是利用统计和计算科学的最新进展来创建新的临床试验设计和数据分析工具，以解决当前临床试验方法学的许多关键科学限制。这些项目的重点是第二阶段和第111阶段临床试验中的实际设计和分析问题、数据缺失问题和预后信息的有效利用、使用临床试验数据的上市后监测和比较有效性研究、药物遗传学和个体化治疗，以及动态治疗方案改善癌症治疗的潜力。拟议的临床试验设计和分析创新有可能改变主流的临床试验范式，并极大地提高新疗法的发现和转化为临床实践的速度。我们的多机构办法包括一个有效和充满活力的进程，以便密集、协调地执行、传播和传播成果，包括为实际执行新制定的方法开发新的软件。我们的全面和新颖的方法将导致癌症临床试验实践的重大改进，从而改善癌症患者的健康。