Miami Treatment and Prevention Clinical Trials Unit (CTU)

迈阿密治疗和预防临床试验中心 (CTU)

• 批准号: 8784167
• 负责人: Margaret A Fischl
• 金额: $ 113.52万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-12 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8784167
• 关键词: AIDS clinical trial group; AIDS prevention; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adult; Affect; Area; Caring; Certification; Childhood; Clinical Research; Clinical Research Associate; Clinical Trials; Clinical Trials Network; Clinical Trials Unit; Communication; Communities; Comorbidity; Data; Doctor of Medicine; Epidemic; Equipment and supply inventories; Evaluation; Feedback; Fostering; Funding; Goals; Good Clinical Practice; HIV; HIV Infections; Hepatitis; Incidence; Infection; International Maternal Pediatric Adolescent AIDS Clinical Trials Group; Laboratories; Leadership; Life; Longevity; Mission; National Institute of Allergy and Infectious Disease; Pharmacists; Pharmacy facility; Policies; Population; Populations at Risk; Positioning Attribute; Prevention; Prevention approach; Prevention strategy; Procedures; Protocols documentation; Qualifying; Quality Control; Records; Recruitment Activity; Reporting; Research; Research Infrastructure; Research Personnel; Resources; Sampling; Specific qualifier value; Specimen Handling; Structure; Testing; Therapeutic; Tuberculosis; United States; Universities; Vaccines; Woman; burden of illness; clinical research site; data management; design; experience; innovation; meetings; metropolitan; patient population; prevent; prevention clinical trial; quality assurance

DESCRIPTION (provided by the applicant): The Miami CTU plans to continue to make substantial contributions to the treatment and prevention of HIV/AIDS. The CTU is structured to participate in four NIAID HIV/AIDS Clinical Research Networks to deliver high impact ground breaking research, as well as, to respond to the rapidly emerging needs of the networks. To accomplish these goals the Miami CTU intends to build upon 25 years of major contributions to the treatment and prevention of HIV infection through continuous NIAID HIV/AIDS research funding. With one of the highest incidences of HIV/AIDS in the U.S. in the Miami metropolitan area, more than 25 years of experience in the design and implementation of clinical trials places the Miami CTU in a unique position to recruit and retain diverse patient populations that are severely impacted by the epidemic. Moreover, the breadth and depth of scientific expertise allow the Miami CTU to contribute to the scientific agenda of the NIAID HIV/AIDS clinical trials networks to address the national priorities for HIV/AIDS research and the needs of the Miami metropolitan affected population. To meet these goals, we intend to establish a Miami HIV/AIDS Clinical Trials Unit (CTU) under multiple PI direction through the integration of the Miami AACTG and IMPAACT groups and the Integrated HIV prevention strategies Vaccines to prevent HIV infections clinical research network. The Miami CTU also integrates three clinical research sites (CRS) into the CTU to effectively meet the needs of the diverse patient populations and of the clinical research networks. The CTU and associated CRS are structured to foster synergy and promote economy of scale, resulting in tangible added-value to the research agenda of the NIAID clinical trials network. RELEVANCE: The mission and overall goal of the Miami CTU aligns with the Networks to reduce the burden of disease and infection and to develop transformative, hypothesis-driven clinical studies that test innovative approaches for the treatment and prevention of HIV infection.

描述（由申请人提供）：迈阿密 CTU 计划继续为艾滋病毒/艾滋病的治疗和预防做出实质性贡献。 CTU 的结构是参与四个 NIAID HIV/AIDS 临床研究网络，以提供高影响力的突破性研究，并响应网络快速出现的需求。为了实现这些目标，迈阿密 CTU 打算通过 NIAID 艾滋病毒/艾滋病研究的持续资助，在 25 年来对治疗和预防艾滋病毒感染做出的重大贡献的基础上再接再厉。迈阿密大都市区是美国艾滋病毒/艾滋病发病率最高的地区之一，在设计和实施临床试验方面拥有超过 25 年的经验，使迈阿密 CTU 处于独特的地位，可以招募和留住受该流行病严重影响的不同患者群体。此外，科学专业知识的广度和深度使迈阿密 CTU 能够为 NIAID 艾滋病毒/艾滋病临床试验网络的科学议程做出贡献，以解决艾滋病毒/艾滋病研究的国家优先事项和迈阿密大都市受影响人群的需求。为了实现这些目标，我们打算通过整合迈阿密 AACTG 和 IMPAACT 小组以及综合艾滋病毒预防策略疫苗预防艾滋病毒感染临床研究网络，在多个 PI 指导下建立迈阿密艾滋病毒/艾滋病临床试验中心 (CTU)。迈阿密 CTU 还将三个临床研究中心 (CRS) 整合到 CTU 中，以有效满足不同患者群体和临床研究网络的需求。 CTU 和相关 CRS 的结构旨在促进协同作用并促进规模经济，从而为 NIAID 临床试验网络的研究议程带来切实的附加值。 相关性：迈阿密 CTU 的使命和总体目标与网络一致，旨在减轻疾病和感染的负担，并开展变革性的、假设驱动的临床研究，测试治疗和预防 HIV 感染的创新方法。