Core F -Clinical Science Core

核心 F - 临床科学核心

基本信息

批准号：
10609768
负责人：
Kara W Chew
金额：
$ 21.46万
依托单位：
UNIVERSITY OF CALIFORNIA LOS ANGELES
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-04-08 至 2027-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10609768
关键词：
AIDS clinical trial group Affect Aging Area Behavioral California Clinic Clinical Clinical Informatics Clinical Protocols Clinical Sciences Cohort Studies Collaborations Collection Communities Conceptions Consent Forms Data Development Education Electronic Health Record Epidemic Ethics Committees Funding Goals Grant HIV HIV Seropositivity HIV prevention trials network Human Human Subject Research Individual Institutional Review Boards International Intervention Investigational New Drug Application Laboratories Link Los Angeles Methods Mission Monitor Participant Patient Recruitments Pharmacy facility Policies Population Prevention Process Protocols documentation Registries Research Research Design Research Personnel Resources Sampling Science Services Specimen Standardization Targeted Research Time Training Translational Research Translations Underrepresented Populations Universities University resources Veterans Vulnerable Populations Work clinical research site community engagement design early phase trial efficacious intervention experience first-in-human high reward high risk human subject implementation framework implementation science institutional biosafety committee interest novel patient oriented patient oriented research pre-clinical prevent prospective protocol development research study sociodemographics symposium volunteer

项目摘要

CORE F: PROJECT SUMMARY/ABSTRACT. The Clinical Science Core provides support for clinical, basic/translational, and behavioral investigators in the conduct of HIV-related research involving human subjects at the University of California, Los Angeles (UCLA), Charles Drew University (CDU), and affiliated centers. The goal of Core F is to support the translation of preliminary and pre-clinical data and ideas into clinical/human studies that advance HIV science and lead to interventions with potential quantifiable impact on the HIV epidemic. The Core will do this by reducing identified barriers to the development and implementation of patient- oriented research. The Core has two Specific Aims: 1. To provide support and training to investigators in the regulatory approval and implementation aspects of biomedical, behavioral, and basic translational patient- oriented research in HIV, and 2. To facilitate patient-oriented research in HIV by increasing access to research participants and generating new collaborations and concepts. The Core offers a streamlined process and consultative services to reduce the time between project conception and funding (supporting clinical protocol development and feasibility assessment for successful grant submissions); reduce the time between funding and the initiation and completion of the research; train and support new investigators and established investigators new to patient-oriented research in regulatory, design, and implementation aspects of human subjects research, to move novel and efficacious interventions from the lab to the clinic (domestically and globally); support mechanistic work that can lead to clinical interventions by increasing access to human samples; promote collaboration through linkage to HIV research networks and data; and engage underrepresented populations in HIV research through the Research Study Volunteer Project (RSVP), a Core-sponsored volunteer registry for individuals with and without HIV interested in participating in HIV-related research, to generate the most informative prevention and treatment studies in key populations. All services of the Core will support both domestic and internationally based research initiatives.

核心 F：项目摘要/摘要。临床科学核心为临床、进行涉及人类受试者的艾滋病毒相关研究的基础/转化和行为研究者加州大学洛杉矶分校 (UCLA)、查尔斯德鲁大学 (CDU) 及其附属中心。这 Core F 的目标是支持将初步和临床前数据和想法转化为临床/人类推动艾滋病毒科学发展并导致对艾滋病毒具有潜在可量化影响的干预措施的研究流行性。核心将通过减少已识别的患者开发和实施障碍来实现这一目标。定向研究。该核心有两个具体目标： 1. 为调查人员提供支持和培训生物医学、行为和基本转化患者的监管批准和实施方面 2. 通过增加研究机会来促进以患者为导向的艾滋病毒研究参与者并产生新的合作和概念。核心提供了简化的流程和咨询服务，以减少项目构思和资助之间的时间（支持临床方案成功提交赠款的开发和可行性评估）；缩短资助和资助之间的时间研究的开始和完成；培训和支持新调查员和已建立的调查员人类受试者研究的监管、设计和实施方面的以患者为导向的研究新手，将新颖有效的干预措施从实验室转移到临床（国内和全球）；支持机械工作可以通过增加人体样本的获取来导致临床干预；推动通过与艾滋病毒研究网络和数据的联系进行合作；并让代表性不足的人群参与通过研究志愿者项目 (RSVP) 进行艾滋病毒研究，这是一个由核心资助的志愿者登记处有兴趣参与艾滋病毒相关研究的感染和未感染艾滋病毒的个人，以产生最多的对重点人群进行信息丰富的预防和治疗研究。核心的所有服务都将支持基于国内和国际的研究举措。