Conference Series: Statistical Issues in Clinical Trials

描述（由申请人提供）：R13-CA 132565的竞争性继续资助申请旨在通过一系列持续的有针对性的研讨会，继续促进临床试验的统计设计，实施和生物统计分析方法的进步，涉及统计学家和临床医生。每个专题讨论会的主题将每年选择一次，根据一个区域的适合性，以受益于集中的专题讨论会，及其对临床试验实践的潜在影响。我们希望研讨会将继续解决问题，并提出解决方案，这些解决方案可以在疾病领域迅速转化，这在历史上一直是生物统计方法的情况，无论是哪个疾病领域激发了其发展。每一个研讨会预计将审查方法的临床，伦理和实践环境的背景下，所考虑的问题。宾夕法尼亚大学拥有一个蓬勃发展的临床和转化医学与治疗研究所（ITMAT），并被授予第一个临床和转化科学奖（CTSA）之一，该奖项巩固并正式化了宾夕法尼亚大学佩雷尔曼医学院及其教师和资源对转化科学的长期承诺。从早期的动物和临床试验到批准干预措施的上市后监测。我们打算继续将CTSA计划的原则纳入拟议的研讨会，以打破传统的研究障碍，实现高效和道德的科学。其目标是发展一系列临床试验专题讨论会，每个专题讨论会侧重于评估干预措施的一个阶段内的一个领域;汇集领先的科学家（统计人员和临床医生）参与介绍和讨论这些领域的最新技术和预期发展;组织者进行会前审查，以便在目标领域建立争议和平衡，并将其纳入计划;寻求既有专门知识又有决心参加专题讨论会的听众;及时在同行评审的期刊上发表专题讨论会的会议记录，包括讨论情况。我们坚信，临床试验方法的性质不是疾病特异性的，尽管在某些医学领域将更多地使用某些方法。在五年的持续资助期内，我们的意图是再举办五次年度单日研讨会。我们的期望是，实现系列会议的这些目标将不仅仅是传递信息，而是通过思想对比和讨论内容扩大现有的最新信息。我们认为，这些与专家和与会者交流意见的重点讨论应促进新的统计方法的发展，以便对干预措施进行更有效、更具成本效益和更符合道德的评价。

DESCRIPTION (provided by applicant): This request for a competitive continuation grant of R13-CA132565 is to continue to facilitate advances in approaches to the statistical design, implementation and biostatistical analysis of clinical trials, through a continuing series of targeted symposia, involving both statisticians and clinicians. The topic for each symposium will be chosen annually, based on the suitability of an area to benefit from a concentrated symposium, and its potential impact on the practice of clinical trials. We expect that the symposia will continue to address problems and produce solutions that translate readily across disease areas, which historically has been the case for biostatistical methodology, regardless of the disease area that inspired its development. Every symposium is expected to examine methodological approaches in the context of the clinical, ethical and practical environments attendant to the problems being considered. The University of Pennsylvania has a flourishing Institute for Clinical and Translational Medicine and Therapeutics (ITMAT) and was awarded one of the first Clinical and Translational Science Awards (CTSA) which has solidified and formalized the long standing commitment of the Perelman School of Medicine at the University of Pennsylvania and its faculty and resources, to translational science, from early animal and clinical testing to post marketing surveillance of approved interventions. It is our intent to continue to incorporate into the proposed symposia a principle of the CTSA Program, to break down traditional research barriers to achieve efficient and ethical science. The objectives are to develop a series of clinical trials symposia, each focused on an area within one of the stages of assessment of an intervention; to bring together leading scientists (statisticians and clinicians) o be involved in the presentation and discussion of the state of the art and expected developments in these areas; to have pre-conference review by organizers in order to establish controversy and equipoise in the targeted area and incorporate such into program; to seek an audience with both expertise and commitment to participate in the symposia; and to publish the proceedings of the symposia, including discussion, in a timely fashion in a peer reviewed journal. We strongly believe that the nature of clinical trials methodology is not disease specific although there will be a heavier use of certain methodologies in some areas of medicine Over a five-year continued grant period, our intent is to develop an additional five annual single day symposia. Our expectation is that meeting these objectives for the conference series will provide more than just a transfer of information, in allowing for an expansion of the available state-of-the-art information through the contrast of ideas and the elements of discussion. It is our belief that these focused discussions with experts and participants exchanging ideas should enhance the development of new statistical methodology for more efficient, cost effective and ethical evaluation of interventions.