Human Subjects Core: Protocols, Statistics, Collaborative Method Development and

人类受试者核心：协议、统计、协作方法开发和

• 批准号: 7499062
• 负责人: Rajita Sinha
• 金额: $ 58.26万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-30 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7499062
• 关键词: Addictive Behavior; Address; Affect; Arts; Behavior; Behavioral; Bioinformatics; Biology; Clinical; Clinical Research; Clinical Sciences; Clinical assessments; Complex; Consultations; Data Analyses; Data Collection; Data Set; Economics; Enrollment; Ensure; Equilibrium; Experimental Designs; Funding; Genetic; Goals; Grant; Health; Human; Hyperphagia; Image Analysis; Individual; Lead; Measures; Meta-Analysis; Methodology; Methods; Minority; Monitor; Participant; Patients; Physiological; Pilot Projects; Process; Protocols documentation; Quality Control; Recruitment Activity; Research; Research Ethics Committees; Research Personnel; Research Project Grants; Resources; Screening procedure; Self-control as a personality trait; Services; Smoking; Social Environment; Stress; System; Training; Translational Research; Translations; Update; Ursidae Family; Woman; addiction; base; concept; data integration; data management; database design; design; drinking; human study; human subject; method development; neurochemistry; ranpirnase; response; social; statistics; tool; web-accessible

The conduct of interdisciplinary and translational clinical research is complex and can be optimized through coordination of specialized resources across projects. This P30 will provide core Human Subjects resources for coordinated and efficient data collection and statistical analysis across the clinical studies and pilot projects included in this consortium. Among the overall goals of the IRCSSA, is the need to study well characterized clinical and non-clinical participants in all human projects so as to achieve both economics of scale and more importantly to synthesize findings on stress, self control and addiction across multiple response systems. This may be achieved by a coordinated and centralized participant recruitment process and by the use of analogous measures to understand the key concepts of stress, self control and addiction across research projects. Furthermore, as multi-system assessments (e.g., genetics, neurochemical, physiological, behavioral, social factors) are being conducted across studies, we plan to create large datasets of common measures across clinical and non-clinical participant groups so as to evaluate the key constructs from multiple perspectives. In this way a Human Subjects P30 that incorporates these services will enhance the synergy between human projects in the IRCSSA. Therefore, the overall aims of this Core are the following: (1) To provide centralized coordination of subject recruitment for clinical studies; (2) To provide a central assessment resource on stress, self control, physical health screening measures and for specific addictive behaviors of smoking, drinking, overeating; (3) To provide central data collection and management resources; (4) To provide centralized and coordinated data analysis and statistics expertise; and (5) To provide scientific support and consultation to ongoing and pilot study investigators. Through these aims the P30 will provide critical support to the human studies and facilitate integration of data across projects in the IRCSSA. Such integration will permit pooled analysis across studies that will lead to a more comprehensive understanding of the stress mechanisms that affect self control processes in addiction.

跨学科和翻译临床研究的行为很复杂，可以优化 通过跨项目的专业资源协调。该P30将提供人类核心主题 在临床研究中进行协调和有效的数据收集和统计分析的资源以及 该财团中包括的试点项目。在IRCSSA的总体目标中，需要很好地学习 在所有人类项目中都表征了临床和非临床参与者，以实现这两种经济学 扩展，更重要的是综合有关压力，自我控制和成瘾的发现 响应系统。这可以通过协调和集中的参与者招聘过程来实现 并通过使用类似的措施来了解压力，自我控制和成瘾的关键概念 跨研究项目。此外，作为多系统评估（例如遗传学，神经化学， 生理，行为，社会因素）正在整个研究中进行，我们计划创建大型 跨临床和非临床参与者组的共同度量数据集，以评估关键 从多个角度进行构造。通过这种方式，人类受试者P30结合了这些服务 将增强IRCSSA人类项目之间的协同作用。因此，该核心的总体目标 如下：（1）提供临床研究的受试者招募的集中协调； （2）至 提供有关压力，自我控制，身体健康筛查措施的中央评估资源以及 吸烟，饮酒，暴饮暴食的具体成瘾行为； （3）提供中央数据收集和 管理资源； （4）提供集中和协调的数据分析和统计专业知识； （5）为正在进行的和试点研究的研究人员提供科学支持和咨询。通过 这些目标P30将为人类研究提供关键支持，并促进跨越数据的整合 IRCSSA的项目。这种整合将允许跨研究的汇总分析，这将导致更多 对影响成瘾的自我控制过程的压力机制的全面理解。