Biomarker Analytic and Regulatory Core

生物标志物分析和监管核心

• 批准号: 10478102
• 负责人: Andrew A Strasser
• 金额: $ 22.74万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-14 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10478102
• 关键词: Address; Advertising; Behavior; Biological Markers; Biometry; Cigarette; Collection; Communities; Creativeness; Data; Data Collection; Databases; Evaluation; Family Smoking Prevention and Tobacco Control Act; Funding Opportunities; Future; Goals; Health; Health Benefit; Infrastructure; Knowledge; Label; Logistics; Marketing; Measures; Nature; Nicotine; Pennsylvania; Perception; PhenX Toolkit; Pilot Projects; Population Assessment of Tobacco and Health; Procedures; Progress Reports; Public Health; Recording of previous events; Regulation; Reporting; Research; Research Personnel; Resources; Science; Structure; Time; Tobacco; Universities; Update; Work; addiction; base; combustible tobacco; cost efficient; data management; data quality; design; experience; innovation; novel; programs; public policy on tobacco; recruit; response; tobacco products; tobacco regulatory science

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.

项目概要 烟草监管科学 (TRS) 是一个快速发展的领域，自 2017 年以来受到众多监管变化的推动 2009 年《家庭吸烟预防和烟草控制法》出台。因为监管行动必须 基于证明公共卫生益处的经验证据，需要数据来告知潜在的 烟草控制政策。 根据我们之前的 TRS 经验，我们认识到需要在内部建立强大的支持基础设施 UP-RU TCORS 利用未来的机会进一步推进 TRS。具体而言，项目可能受益 很大程度上取决于现有的基础设施来支持：1）新颖的分析方法、数据测量和 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，我们提出了专用的生物样本、分析和监管 (BAR) 核心 建立这一基础设施，并提供这些各自领域的既定研究人员的支持，这些研究人员 在 TRS 新兴领域也拥有丰富的知识。 BAR 核心的总体目标是最大限度地提高 UP-RU 内开展的项目的贡献 TCORS 到 TRS。 BAR 核心的首要目标是支持中心内的主要项目 统一的措施、数据收集和分析资源。这包括使用类似的措施 在我们提出的研究中，与 PATH、PhenX 和其他大规模计划、研究招募保持一致 物流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，以便更好地使其与 中心项目，并在 TRS 研究界产生更大的影响。我们将聚集专家 烟草相关的生物样本工作、烟草研究特定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规划的形成阶段，我们将引进生物统计学、生物样本方面的专家 收集和分析以及监管备案，以加强我们拟议的项目。 BAR 核心研究人员是每个核心领域（生物样本、分析和监管）的专家， 并拥有开展 TRS 相关研究的历史。正是这个特定的关键交叉点 推进科学发展所需的领域知识和对 TRS 研究的理解。这个核心 将是协调主要项目和程序的措施和程序的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。