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）：这个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，这些方法可以加速成功地将有效的新疗法引入实践。方法的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的许多关键科学局限性。这些项目着重于第二阶段和第111阶段临床试验中的实践设计和分析问题，使用临床试验数据，药物遗传学和个性化疗法以及动态治疗方案的潜力来改善癌症治疗的潜力，使用了数据缺失以及有效地使用预后信息的问题，进行了市场后的监视和比较有效性研究。拟议的临床试验设计和分析创新有可能改变现行的临床试验范式，并大大提高了新疗法的发现和翻译为临床实践的速度。我们的多机构方法包括一个有效且充满活力的过程，用于激烈，协调的实施，沟通和结果传播，包括开发新软件以实际实施新开发的方法。我们全面而新颖的方法将导致癌症临床试验实践的重大改善，从而改善癌症患者的健康状况。