Biomarker Analytic and Regulatory Core

项目总结 烟草监管科学(TRS)是一个快速发展的领域，自 2009年《家庭吸烟预防和烟草控制法》的颁布。因为监管行动必须 基于证明公共健康益处的经验证据，需要数据来告知潜在的 烟草控制政策。 根据我们以往的TRS经验，我们认识到有必要在 Up-RU TCORS利用未来的机会进一步发展TRS。具体地说，项目可能受益 极大地得益于拥有可支持的现有基础设施：1)新的分析方法、数据测量和 数据管理；2)生物样本收集、分析和存储；以及3)监管备案和报告 结构。为了满足这一需求，我们提出了一个专门的生物样本、分析和监管(BAR)核心来 建立这一基础设施，并从这些领域的成熟调查人员那里提供支持 在TRS这一新兴领域也有很强的知识。 BAR核心的总体目标是最大限度地发挥在UP-RU内进行的项目的贡献 TCORS呼叫TRS。BAR核心的第一个目标是支持中心内的主要项目，包括 统一的衡量标准、数据收集和分析资源。这包括使用类似的措施 在我们建议的研究中，与Path、PhenX和其他大规模计划保持一致，研究招募 物流和集中数据质量检查和保证活动。Bar Core的第二个目标是 支持具有生物样本、分析和监管专门知识的试点项目，以便更好地使其符合 中心项目，并在TRS研究社区有更大的影响。我们将召集专家到 与烟草有关的生物抽样工作、针对烟草研究的统计方法和数据收集 要求。BAR核心的最终目标是通过生物样本、分析和监管来支持RRP 专业知识。在RRP计划的形成阶段，我们将引入生物统计学、生物样本方面的专家 收集和分析，以及监管备案，以提高我们的建议项目。 BAR核心调查人员是核心的每个领域(生物样品、分析和监管)的专家， 并有进行TRS相关研究的既定历史。正是这种特定的关键交汇点 领域知识和对TRS研究的理解，这是推进科学所需的。这个核心 将是协调主要项目的措施和程序的一种具有成本效益的办法， 在试点项目和RRP计划中支持创新和创造力。

PROJECT SUMMARY Tobacco regulatory science (TRS) is a rapidly evolving field driven by numerous regulatory changes since the inception of the 2009 Family Smoking Prevention and Tobacco Control Act. Because regulatory actions must be based on empirical evidence that demonstrate public health benefits, data are needed to inform potential tobacco control policies. Based on our previous TRS experience, we recognize the need for strong supporting infrastructure within the UP-RU TCORS to take advantage of future opportunities to further TRS. Specifically, projects may benefit greatly from having an existing infrastructure to support: 1) novel analytic approaches, data measures, and data management; 2) biosample collection, analysis, and storage; and 3) regulatory filing and reporting structure. To address this need, we propose a dedicated Biosample, Analytic and Regulatory (BAR) Core to establish this infrastructure and provide support from established investigators in these respective fields who also have strong knowledge in the emerging field of TRS. The overall goal of the BAR Core is to maximize the contributions of projects conducted within the UP-RU TCORS to TRS. The first aim of the BAR Core is to support within-center primary projects with harmonized measures, data collection, and analytic resources. This includes using similar measures across our proposed studies, aligning with PATH, PhenX and other large scale initiatives, study recruitment logistics and centralized data quality check and assurance activities. The second aim of the BAR Core is to support pilot projects with biosample, analytic and regulatory expertise, in order to better align them with center projects and have a greater impact in the TRS research community. We will assemble experts in tobacco-related biosample work, tobacco research-specific statistical approaches and data collection requirements. The final aim of the BAR Core is to support RRPs with biosample, analytic and regulatory expertise. At the formative stages of RRP planning, we will bring in experts in biostatistics, biosample collection and analysis, and regulatory filing, in order to enhance our proposed projects. BAR Core investigators are experts in each of the Core's domains (Biosamples, Analytics, and Regulatory), and have an established history of conducting TRS-relevant research. It is this critical intersection of specific domain knowledge and the understanding of TRS research that is needed to advance the science. This core will be a cost-efficient approach to harmonizing measures and procedures of the primary projects and supporting innovation and creativity in the pilot projects and RRP Program.