Statistical Methods for Cancer Clinical Trials

描述（由申请人提供）：这个雄心勃勃的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，从而加速将有效的新疗法成功引入实践。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，解决当前临床试验方法的许多关键科学限制。这些项目侧重于II期和111期临床试验的实际设计和分析问题、数据缺失和预后信息的有效利用问题、上市后监测和使用临床试验数据的比较有效性研究、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。提出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，并大大提高新疗法的发现和转化为临床实践的速度。我们的多机构方法包括一个有效和积极的过程，以加强、协调的实施、沟通和传播结果，包括为实际实施新开发的方法开发新的软件。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进，从而改善癌症患者的健康状况。

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.