Biomarker Analytic and Regulatory Core

项目摘要 烟草监管科学（TRS）是一个快速发展的领域，自2000年以来， 《2009年家庭吸烟预防和烟草控制法》。因为监管行动必须 基于证明公共卫生效益的经验证据，需要数据来告知潜在的 烟草控制政策。 根据我们之前的TRS经验，我们认识到需要强大的支持基础设施 UP-RU TCORS利用未来的机会进一步TRS。具体而言，项目可能会受益 这在很大程度上取决于现有的基础设施，以支持：1）新颖的分析方法，数据测量， 数据管理; 2）生物样本采集、分析和储存; 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品、分析和监管（BAR）核心， 建立这一基础设施，并由这些领域的资深调查员提供支助， 在新兴的TRS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UP-RU内进行的项目的贡献 TCORS到TRS。BAR核心的首要目标是支持中心内的主要项目， 协调措施、数据收集和分析资源。这包括使用类似的措施 在我们提出的研究，与PATH对齐，PhenX和其他大规模的举措，研究招聘 后勤和集中数据质量检查和保证活动。BAR核心的第二个目标是 利用生物样本、分析和监管专业知识支持试点项目，以便更好地与 中心项目，并在TRS研究界产生更大的影响。我们将召集专家， 与烟草有关的生物样本工作、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、分析和监管支持RRPs 专业知识在RRP规划的形成阶段，我们将引入生物统计学、生物样本 收集和分析，并监管备案，以提高我们的建议项目。 BAR核心研究者是核心领域（生物样品、分析和监管）的专家， 并具有进行TRS相关研究的既定历史。正是这种特定的 领域知识和对TRS研究的理解，这是推进科学所需的。这一核心 将是协调主要项目的措施和程序的一种具有成本效益的方法， 支持试点项目和RRP计划中的创新和创造力。

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.