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Conference Series: Statistical Issues in Clinical Trials

会议系列：临床试验中的统计问题

基本信息

批准号：
8459288
负责人：
JONAS H ELLENBERG
金额：
$ 0.75万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-12-17 至 2013-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8459288
关键词：
Address American Animal Testing Area Award Awareness Belief Biometry Canada Clinical Clinical Medicine Clinical Sciences Clinical Trials Clinical and Translational Science Awards Complex Development Disease Elements Environment Equipoise Ethics Europe Evaluation Faculty Floor Funding Good Clinical Practice Grant Human Institutes International Intervention Journals Medicine Methodology Methods Modeling Nature Paper Participant Peer Review Pennsylvania Process Public Health Publications Publishing Research Research Infrastructure Resources Schedule Science Scientist Series Societies Solutions Staging Statistical Methods Surveys Therapeutic Translating Translational Research Universities base cost effective design drug development expectation experience medical schools meetings post-market programs public health relevance research clinical testing sound symposium translational medicine

项目摘要

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.

描述（由申请人提供）：本申请R13-CA132565的竞争性持续拨款是为了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，通过持续的一系列有针对性的专题讨论会，包括统计学家和临床医生。每次研讨会的主题将根据一个领域是否适合从集中的研讨会中受益，以及它对临床试验实践的潜在影响，每年选择一次。我们期望专题讨论会将继续解决问题并产生易于跨疾病领域转化的解决方案，这在历史上一直是生物统计方法的情况，无论激发其发展的疾病领域如何。预计每一次专题讨论会都将在临床、伦理和实际环境的背景下审查与所考虑的问题有关的方法方法。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），并获得了首批临床和转化科学奖（CTSA）之一，这巩固并正式确立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，从早期动物和临床试验到批准干预措施的上市后监督。我们的意图是继续将CTSA计划的原则纳入拟议的专题讨论会，以打破传统的研究障碍，实现高效和道德的科学。目标是开展一系列临床试验专题讨论会，每个专题讨论会侧重于干预评估阶段中的一个领域；汇集领先的科学家（统计学家和临床医生），参与介绍和讨论这些领域的最新进展和预期发展；由组织者在会前进行审查，以便在目标领域建立争议和平衡，并将其纳入计划；寻求具有专业知识和承诺的听众参加专题讨论会；并及时在同行评议的期刊上发表专题讨论会的会议记录，包括讨论。我们坚信临床试验方法学的本质不是针对特定疾病的，尽管在某些医学领域会更多地使用某些方法学。在为期5年的持续拨款期内，我们的目的是开发额外的5个年度单日专题讨论会。我们的期望是，实现系列会议的这些目标将提供的不仅仅是信息的传递，还将允许通过思想和讨论内容的对比来扩大现有的最新信息。我们认为，与专家和与会者交换意见的这些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、更具成本效益和合乎道德的评价。