From Bench to Bedside to Community:Statistical Issues in the Early to Late Assess

从实验室到临床到社区：早期到晚期评估中的统计问题

• 批准号: 7541467
• 负责人: JONAS H ELLENBERG
• 金额: $ 3.09万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-17 至 2012-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7541467
• 关键词: Address; Animals; Area; Arts; Clinical; Clinical Trials; Communities; Development; Disease; Dose; Elements; Environment; Equipoise; Ethics; Goals; Human; Intervention; Journals; Laboratory Study; Methodology; Methods; Motivation; Peer Review; Publications; Publishing; Scientist; Series; Solutions; Staging; Structural Models; Translating; base; bench to bedside; design; expectation; meetings; post-market; programs; sound; symposium; therapy development

DESCRIPTION (provided by applicant): There is a continuing need for the development of scientifically sound, efficient, ethical, and safe methods for the assessment of human interventions. The motivation for this proposal is to facilitate advances in approaches to the statistical design, implementation and biostatistical analysis of clinical trials, through a continuing series of targeted symposia. Each symposium will focus entirely on an area approximately within commonly accepted definitions of stages in the development of an intervention (animal and laboratory studies, early human and dose finding studies, early efficacy and transition studies, definitive efficacy studies, post marketing studies). 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 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 statistical methodological approaches in the context of the clinical, ethical and practical environments attendant to the problems being considered. The structural model for the conference roughly involves getting the cogent thinkers of the day in a particular area together to make formal presentations, create an environment for active discussion, and importantly, provide rapid publication (goal, one year from conference). Our specific objectives are to: develop a series of clinical trials symposia, each focused on an area within one of the five stages of assessment of an intervention; bring together leading scientists to 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; to publish the proceedings of the symposia, including discussion, as quickly as possible in a peer reviewed journal. Our expectation is that meeting these objectives for the conference series will provide more than just a transfer of information, allowing for an expansion of the available state-of-the-art information through the contrast of ideas and the elements of discussion.

描述（由申请人提供）：持续需要开发科学合理、有效、道德和安全的方法来评估人类干预。 该提案的动机是通过持续举办一系列有针对性的研讨会，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。 每个专题讨论会将完全集中在一个领域，大约在普遍接受的定义阶段的发展干预（动物和实验室研究，早期人体和剂量探索研究，早期疗效和过渡研究，确定性疗效研究，上市后研究）。 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。 我们希望研讨会将解决问题，并产生跨疾病领域的解决方案，这在历史上一直是生物统计方法的情况下，无论疾病领域，激发了它的发展。 每一个研讨会预计将审查统计方法的临床，伦理和实践环境的背景下，所考虑的问题。 会议的结构模式大致包括将当天某个特定领域的有说服力的思想家聚集在一起进行正式演讲，创造一个积极讨论的环境，重要的是，提供快速出版物（目标，会议一年后）。 我们的具体目标是：举办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五个阶段之一的一个领域;汇集顶尖科学家，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;尽快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。