Clinical Investigation Core

临床研究核心

• 批准号: 8259521
• 负责人: Robert Stephen Klein
• 金额: $ 64.67万
• 依托单位: ALBERT EINSTEIN COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-05-15 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8259521
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Adolescent; Applications Grants; Behavioral; Behavioral Sciences; Caring; Child health care; Clinic; Clinical; Clinical Data; Clinical Research; Clinical Sciences; Clinical Trials; Collaborations; Communicable Diseases; Consultations; Data; Data Analyses; Databases; Development; Elements; Eligibility Determination; Enrollment; Epidemiology; Evaluation; Funding; HIV; HIV Infections; HIV-1; Human; Individual; Information Systems; Institutional Review Boards; International; Intervention Studies; Laboratories; Life; Link; Medical center; Mentors; Patients; Persons; Preparation; Prevention; Preventive; Psychiatry; Publications; Recommendation; Research; Research Design; Research Personnel; Research Project Grants; Research Subjects; Resources; Retrieval; Risk; Sampling; Scientist; Services; Social Sciences; Specimen; Substance abuse problem; System; Translational Research; analytical method; behavioral/social science; clinical care; clinical research site; design; human subject; interest; meetings; member; population health; programs; research study; social; social science research; user-friendly

The primary objectives of the Clinical Investigation Core are to facilitate the ability of CFAR investigators to initiate or expand HIV/AIDS research projects that require access to HIV-1 -infected individuals, clinical specimens and/or or data, and to mentor junior and other new investigators in both clinical and social and behavioral HIV-related research. The Core will provide CFAR members with access to robust databases with demographic, clinical, and laboratory data from among patients and others enrolled in clinical research studies. Queries to these databases can provide access to previously collected data and facilitate rapid access to subjects who meet eligibility criteria for new studies. The clinical settings include the AIDS Research Program of the Department of Epidemiology and Population Health, the Division of Substance Abuse, the AIDS Center Infectious Diseases Clinic, the Adolescent AIDS Program, and a new Social and Behavioral Component that includes the Prevention Intervention Research Center. The Core also will provide assistance in study design, including recommendations for sample selection, power calculations and the use of appropriate analytical methods. The Core has developed a centralized, user-friendly, efficient gateway to provide access to data across clinical care and clinical research sites, to facilitate clinical research, and to stimulate interactions among clinical and laboratory investigators to promote translational research. Mentoring sessions at which senior investigators mentor junior and new investigators will continue. Finally, the Core will facilitate new international research initiatives. The Specific Aims are: 1) To facilitate the retrieval and sharing of clinical data currently available in disparate data systems; 2) To assist in identifying individuals and/or their specimens for new research projects; 3) To expedite informing potential human subjects of new and ongoing research projects and facilitate interactions between potential research subjects and investigators; 4) To assist clinical, social science, and basic researchers in achieving rigor of study design and validity and generalizability of study results by providing expertise in sample selection, study design, power calculations, and appropriate analytical methods; 5) To mentor junior and new investigators in all aspects of HIV-related research, including study design, subject enrollment, IRB requirements, collaboration with basic scientists, preparation and resubmission of grant applications, and presentation and publication of research findings; 6) To increase the capacity of investigators to perform studies involving social and behavioral elements, and to build social science studies into existing or new clinical research, through state-of-the-art consultation and support services in the social and behavioral sciences; 7) To expand international HIV-related research; and 8) To educate clinicians about the latest developments in HIV research to stimulate interest in investigating important unresolved clinical research questions.

临床研究核心的主要目标是促进CFAR研究者的能力 启动或扩展需要访问HIV -1感染者的艾滋病毒/艾滋病研究项目，临床 标本和/或数据，以及指导临床和社会和其他新调查员的指导 行为HIV相关的研究。核心将为CFAR成员提供对强大数据库的访问 来自患者和其他参与临床研究的患者的人口，临床和实验室数据 研究。这些数据库的查询可以提供对先前收集的数据的访问，并促进快速 访问符合新研究资格标准的受试者。临床设置包括艾滋病 流行病学和人口健康部研究计划，物质司 虐待，艾滋病中心传染病诊所，青少年艾滋病计划以及一个新的社会和 行为组成部分，包括预防干预研究中心。核心也将 在研究设计方面提供帮助，包括针对样品选择，电源计算和 使用适当的分析方法。核心已经开发了一种集中式，用户友好，高效的 网关可提供跨临床护理和临床研究站点的数据访问，以促进临床 研究，并刺激临床和实验室研究人员之间的相互作用以促进翻译 研究。指导会议将继续进行高级调查员指导初级和新调查人员的指导会议。 最后，核心将促进新的国际研究计划。具体目的是：1）促进 目前在不同数据系统中可用的临床数据的检索和共享； 2）协助识别 个人和/或其新研究项目的标本； 3）加快告知潜在人类的信息 新的和正在进行的研究项目的主题，并促进潜在研究对象之间的互动 和调查人员； 4）协助临床，社会科学和基础研究人员实现严格的研究 设计和有效性以及研究结果的有效性以及通过提供样本选择的专业知识，研究 设计，功率计算和适当的分析方法； 5）指导初级和新调查员 HIV相关研究的所有方面，包括研究设计，受试者注册，IRB要求， 与基础科学家合作，准备和重新提交赠款申请以及演示文稿以及 研究发现的出版； 6）提高调查人员进行涉及研究的能力 社会和行为因素，并将社会科学研究建立在现有或新的临床研究中， 通过最新的社会和行为科学咨询和支持服务； 7） 扩大国际HIV相关研究； 8）教育临床医生有关艾滋病毒的最新发展 刺激对研究重要未解决的临床研究问题的兴趣的研究。