University of Rochester HIV/AIDS Clinical Trials Unit

罗切斯特大学艾滋病毒/艾滋病临床试验单位

• 批准号: 10532191
• 负责人: Stephen Dewhurst
• 金额: $ 175.8万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-01 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10532191
• 关键词: AIDS clinical trial group; Acceleration; Address; Affect; Area; Attitude; Awareness; Biological Assay; Capital; Clinical Research; Clinical Trials; Clinical Trials Unit; Communicable Diseases; Communication; Communities; Community Health Education; Cost efficiency; Coupled; Data; Education; Education and Outreach; Electronic Medical Records and Genomics Network; Ensure; Equipment and supply inventories; Evaluation; Guidelines; HIV; HIV Infections; HIV Vaccine Trials Network; HIV vaccine; HIV/AIDS; Infrastructure; Intervention; Laboratories; Leadership; Measures; Mentors; Mission; National Institute of Allergy and Infectious Disease; Occupational activity of managing finances; Participant; Performance; Pharmacists; Pharmacy facility; Population; Population Heterogeneity; Preventive vaccine; Procedures; Protocols documentation; Qualifying; Regulation; Research; Research Activity; Research Personnel; Resource Allocation; Resource Sharing; Resources; Science; Scientific Advances and Accomplishments; Secure; Shipping; Specific qualifier value; Specimen Handling; Training; Translational Research; Universities; burden of illness; clinical research site; clinical translation; clinical trial enrollment; community engagement; data management; efficacy evaluation; flexibility; follow-up; improved; innovation; instrument; member; next generation; participant enrollment; programs; recruit; response; success

The University of Rochester (UR) Infectious Diseases Division (IDD) has meaningfully contributed to the NIAID HIV/AIDS Clinical Research Networks (CRNs) for over 30 years. The enduring mission of the UR Clinical Trials Unit (CTU) is to support and conduct clinical research on HIV/AIDS that contributes to the discovery of a preventive vaccine for HIV, as well as to the discovery of a cure for HIV, and of treatments that reduce the burden of disease due to HIV infection and its complications. It will acheive this mission by providing exceptional scientific and administrative leadership, and outstanding clinical trials infrastructure, and by engaging with all relevant stakeholders and communities, to ensure that the research it conducts is responsive to community needs. Five aims are proposed. The first is to strengthen our well-established Clinical Research Sites (CRSs). To do this, we will support 2 domestic CRSs that will participate in the following NIAID CRNs: (i) the `AIDS Clinical Trials Group' (ACTG); and (ii) the `HIV Vaccine Trials Network' (HVTN). We will also develop a plan to diversify UR CTU leadership, and to enhance integration and coordination of these CRSs. The second aim is to provide exceptional administrative leadership that accelerates and enhances NIAID clinical research. We will do this by continuing and enhancing effective financial management procedures and a robust quality management program, and by continuously assessing well-defined metrics of operational performance and capacity; these measures will be used to determine improvement opportunities that will be addressed by targeted actions and follow-up evaluation to assess the efficacy of such interventions. Performance data will be coupled to resource allocation, and poorly performing CTU components will be terminated, if necessary. The third aim is to provide exceptional scientific leadership that promotes important contributions to the advancement of HIV/AIDS science, and mentors the next generation of CTU researchers. The CTU will oversee and coordinate groundbreaking research activities at the participating CRSs, develop and execute a strong research agenda for the ACTG and HVTN, mentor and train the next generation of CTU researchers, and draw upon campus-wide intellectual capital. Aim four will provide outstanding clinical trials infrastructure, including data and quality management, regulatory support, laboratory, pharmacy and other resources. Innovations will include procedures that facilitate flexibility and surge capacity, allowing a rapid response to emerging Network needs, as well as shared resources that promote cost efficiency. Finally, our fifth aim is to communicate and engage effectively with all UR CTU stakeholders. The Rochester Community Advisory Board (CAB) and our diverse Community Education and Recruitment (CER) Team will engage with local communities, to increase community awareness and education, and facilitate recruitment and retention of research participants. Finally, we will also continue highly responsive communication and engagement with NIAID, its CRNs, and all other key constituencies.

罗切斯特大学（UR）传染病分部（IDD）有意义地为NIAID做出了贡献 艾滋病毒/艾滋病临床研究网络（CRN）已有30多年了。 UR临床试验的持久任务 单位（CTU）将支持和进行有关艾滋病毒/艾滋病的临床研究，这有助于发现 艾滋病毒的预防性疫苗，以及发现艾滋病毒的治疗方法，以及减少的治疗方法 由于艾滋病毒感染及其并发症引起的疾病负担。它将通过提供杰出性来实现这一任务 科学和行政领导以及出色的临床试验基础设施，并与所有人互动 相关的利益相关者和社区，以确保其进行的研究对社区有回应 需要。提出了五个目标。首先是加强我们公认的临床研究地点（CRS）。 为此，我们将支持2个国内CRS，这些CRS将参与以下Niaid CRN：（i）``艾滋病'' 临床试验组（ACTG）； （ii）“ HIV疫苗试验网络”（HVTN）。我们还将制定一个计划 多元化的CTU领导能力，并增强这些CRS的整合和协调。第二个目标是 提供卓越的行政领导，加速和增强NIAID临床研究。我们 将通过继续和增强有效的财务管理程序和良好质量来做到这一点 管理计划，并通过不断评估定义明确的操作绩效指标和 容量;这些措施将用于确定将解决的改进机会 有针对性的行动和后续评估，以评估此类干预措施的功效。性能数据将 与资源分配相结合，如果需要，将终止执行的CTU组件。 第三个目的是提供卓越的科学领导，以促进对 艾滋病毒/艾滋病科学的进步，并指导下一代CTU研究人员。 CTU将监督 并协调参与的CRSS的开创性研究活动，开发和执行强大 ACTG和HVTN的研究议程，导师和培训下一代CTU研究人员，并吸引 在校园范围内的智力资本上。 AIM四将提供出色的临床试验基础设施，包括 数据和质量管理，监管支持，实验室，药房和其他资源。创新会 包括促进灵活性和激增能力的程序，从而可以快速响应新兴网络 需求以及共享的资源来促进成本效率。最后，我们的第五个目标是交流和 有效地与所有CTU利益相关者互动。罗切斯特社区顾问委员会（CAB）和我们的 多样化的社区教育和招聘团队将与当地社区互动，以增加 社区意识和教育，并促进研究参与者的招聘和保留。最后， 我们还将继续与NIAID，其CRN和所有其他 关键选区。