University of Pittsburgh Clinical Trials Unit

匹兹堡大学临床试验单位

• 批准号: 8230290
• 负责人: John W Mellors
• 金额: $ 7.58万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-02-22 至 2011-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8230290
• 关键词: AIDS clinical trial group; AIDS/HIV problem; Address; Area; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Unit; Commit; Communities; Data; District of Columbia; Enrollment; Epidemic; Evaluation; Funding; Goals; HIV-1; Immunology; Infection; Laboratories; Leadership; Mentors; Microbicide Trials Network; Participant; Pennsylvania; Performance; Phase; Population; Prevention; Protocols documentation; Publications; Recruitment Activity; Research; Research Personnel; Scientific Advances and Accomplishments; Site; Translational Research; Universities; Vaccine Research; Weight; West Virginia; Woman; clinical research site; cost; data management; drug development; experience; microbicide; protocol development; research and development; rural area; therapeutic vaccine; treatment strategy; treatment trial; urban area; vaccine development; virology

This application from the University of Pittsburgh proposes an HIV/AIDS Clinical Trials Unit (Pitt CTU) consisting of two Clinical Research Sites (CRS), one at the University of Pittsburgh affiliated with the AIDS Clinical Trials Group (ACTG) and the Microbicide Trials Network (MTN), and one at Georgetown University affliliated with the ACTG. Both Networks have selected the Pitt CTU for affiliation. The Pitt CTU began conducting HIV/AIDS clinical trials in 1986 and has since acquired broad experience in Phase I-IV studies. Under the leadership of J. Mellors (PI), the Pitt CTU became a DAIDS-funded ACTG Unit in 2000. The Georgetown University CRS joined the Pitt CTU in 2001 and remains the only access to DAIDS-sponsored treatment trials in Washington, DC. The Pitt CTU has been a top performing site in the ACTG over the past three years, ranking 5th out of 34 sites in cost efficiency (cost per weighted accrual) and 9th of 34 sites in weighted accrual, with consistently outstanding scores for data management. This strong performance has continued during the current evaluation period (July 2004 - June 2005), with the Pitt CTU ranking 3rd of 34 sites in total accrual, 5th in cost efficiency, 8th in accrual of women, and 4th in data performance. Both the Georgetown and Pitt sites are responsible for this excellent performance. In addition, Pitt CTU investigators have made important contributions to the scientific accomplishments of the ACTG through protocol development, membership on scientific committees, and publication of research findings. The specific aims of the Pitt CTU for this application are: 1) to provide access to DAIDS-sponsored clinical trials for difficult-to-reach populations heavily impacted by the HIV/AIDS epidemic in Washington, DC, and in rural and urban areas of western Pennsylvania and West Virginia, where no other access exists; 2) to recruit, screen, and enroll a minumum of 420 participants during the project period in trials addressing the priority areas of translational research and drug development, optimization of clinical management, therapeutic vaccine research and development, and microbicides; 3) to advance the scientific agenda of both Networks by developing research protocols, serving on scientific and leadership committees, and directing virology and immunology speciality laboratories; 4) to involve and mentor new investigators in HIV/AIDS clinical research; and 5) to partner with the community throughout these endeavors. The investigators and staff of the Pitt CTU are committed to the goal of reducing the impact of the HIV/AIDS epidemic worldwide through translational research to define optimal strategies for treatment and prevention of HIV-1 infection and its complications.

匹兹堡大学的这份申请提出了一个艾滋病毒/艾滋病临床试验单位（Pitt CTU），由两个临床研究中心（CRS）组成，一个在匹兹堡大学附属于艾滋病临床试验组（ACTG）和杀微生物剂试验网络（MTN），一个在乔治敦大学附属于ACTG。这两个网络都选择了皮特反恐组作为附属机构。 皮特CTU于1986年开始进行艾滋病毒/艾滋病临床试验，并在I-IV期研究中获得了广泛的经验。在J. Mellors（PI）的领导下，皮特CTU于2000年成为DAIDS资助的ACTG单位。乔治敦大学CRS于2001年加入皮特CTU，并且仍然是唯一获得DAIDS赞助的在华盛顿的治疗试验的途径。在过去三年中，皮特CTU一直是ACTG中表现最好的站点，在成本效率（每加权应计成本）方面在34个站点中排名第5，在加权应计方面在34个站点中排名第9，数据管理得分一直很高。在当前的评估期间（2004年7月至2005年6月），这一强劲的业绩继续保持，皮特CTU在34个地点中的总收益排名第三，成本效率排名第五，妇女收益排名第八，数据性能排名第四。乔治敦和皮特的网站都负责这一出色的表现。此外，皮特CTU的研究人员通过制定方案、加入科学委员会和发表研究成果，为ACTG的科学成就做出了重要贡献。 皮特CTU的具体目标是：1）为华盛顿、宾夕法尼亚州西部和西弗吉尼亚州的农村和城市地区受艾滋病毒/艾滋病流行病严重影响的难以接触的人群提供获得艾滋病毒/艾滋病资助的临床试验的机会，这些地区没有其他途径; 2）在项目期间招募、筛选和招募至少420名参与者，参与涉及转化研究和药物开发、优化临床管理等优先领域的试验，治疗性疫苗的研究和开发以及杀微生物剂; 3）通过制定研究方案，在科学和领导委员会任职，指导病毒学和免疫学专业实验室，推进两个网络的科学议程; 4）让新的研究人员参与并指导艾滋病毒/艾滋病临床研究;（5）在这些努力中与社区合作。皮特CTU的调查人员和工作人员致力于通过转化研究来确定治疗和预防HIV-1感染及其并发症的最佳策略，从而减少艾滋病毒/艾滋病流行在全球范围内的影响。