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重大贡献。 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，并响应网络的快速新兴需求。为了实现这些目标，迈阿密CTU打算通过连续的NIAID HIV/AIDS研究资金来建立25年为治疗和预防HIV感染的重大贡献。在迈阿密大都市地区，美国艾滋病毒/艾滋病的最高事件之一是，在临床试验的设计和实施方面拥有25年以上的经验，使迈阿密CTU处于招募和​​保留多样化的患者人群的独特地位，这些患者受到该流行病的严重影响。此外，科学专业知识的广度和深度使迈阿密CTU能够为NIAID HIV/AIDS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以及迈阿密大都会影响人群的需求。为了实现这些目标，我们打算通过整合迈阿密AACTG和InmaCACT组和综合的HIV预防策略疫苗，以在多个PI方向下建立迈阿密HIV/AIDS临床试验单元（CTU），以防止HIV感染临床研究网络。迈阿密CTU还将三个临床研究地点（CRS）整合到CTU中，以有效地满足多样化的患者人群和临床研究网络的需求。 CTU和相关的CR结构构成以促进协同作用和促进规模经济，从而使NIAID临床试验网络的研究议程添加了切实的附加价值。 相关性：迈阿密CTU与网络一致的任务和整体目标，以减轻疾病和感染的负担，并开发具有变革性的，假设驱动的临床研究，以测试用于治疗和预防HIV感染的创新方法。