Harvard/Boston/Providence Clinical Trials Unit (Harvard/B/P CTU)

描述（由申请人提供）：将成立哈佛/波士顿/普罗维登斯临床试验单位（CTU），以开展临床试验，解决NIAID四个HIV临床研究网络的研究领域：HIV感染疫苗（HVTN）; HIV综合预防策略（HPTN）;杀微生物HIV预防策略（MTN）;和成人艾滋病毒治疗策略，包括艾滋病毒治愈，非感染性共病和病毒性肝炎和结核病（ACTG）的感染性共病的管理。CTU将由开展临床试验的机构的7个临床研究中心（CRS）组成。这些机构是贝斯以色列女执事医疗中心，马萨诸塞州总医院，布里格姆妇女医院，芬威健康中心，波士顿医疗中心和米里亚姆医院。CTU将由三位经验丰富的PI领导，拉斐尔·多林博士，肯尼斯·迈耶博士和丹尼尔·库里茨克斯博士，并将包括高度成就的CRS领导人和合作调查员。反恐股将作为一个高度合作的综合实体运作，通过一个有效的行政计划进行集中规划、资源分配、决策和财务管理。决策将由严格的评估过程驱动，评估过程基于既定的绩效指标以及CTU和CRS领导层和工作人员之间的有力沟通。CTU的集中资源包括临床研究实验室，研究药房协调员，数据和质量管理计划以及社区参与核心。CTU拥有多样化和可访问的研究人群，代表受艾滋病毒/艾滋病，丙型肝炎病毒感染和结核病影响最严重的社区，并与他们所在的社区建立了良好的联系。CTU已做好充分准备，开展高效、高质量的临床试验，以解决艾滋病毒临床研究中的主要问题。它的领导和行政结构将有助于进行跨越传统网络界限的研究，并能够对新出现的科学方向作出迅速反应。

DESCRIPTION (provided by applicant): The Harvard/Boston/Providence Clinical Trial Unit (CTU) will be established to conduct clinical trials to address research areas of four NIAID HIV Clinical Research Networks: vaccines against HIV infection (HVTN); integrated HIV prevention strategies (HPTN); microbicidal HIV prevention strategies (MTN); and adult HIV therapeutic strategies including HIV cure, management of non-infectious co-morbidities and infectious co-morbidities of viral hepatitis and tuberculosis (ACTG). The CTU will be comprised of seven clinical research sites (CRSs) at institutions where the clinical trials will be conducted. These institutions are Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Brigham and Women's Hospital, Fenway Health Center, Boston Medical Center, and Miriam Hospital. The CTU will be led by three highly experienced PIs, Drs. Raphael Dolin, Kenneth Mayer, and Daniel Kuritzkes, and will include highly accomplished CRS leaders and collaborating investigators. The CTU will function as an integrated, highly collaborative entity, which will have centralized planning, resource allocation, decision-making and financial management through an efficient administration plan. Decisions will be driven by a rigorous evaluation process based on established metrics of performance and robust communication among leadership and staff of the CTU and CRSs. Centralized resources of the CTU include a Clinical Research Laboratory, a Research Pharmacy Coordinator, Data and Quality Management Plans, and a Community Engagement Core. The CTU has diverse and accessible populations for study, representing communities most affected by HIV/AIDS, hepatitis C virus infection and tuberculosis, and have well-grounded connections with the communities in which they are based. The CTU is well poised to carry out efficient, high quality clinical trials to address major questions in HIV clinical research. Its leadership and administrative structure will facilitate the conduct of studies which cross traditional network boundaries and will enable rapid responses to new scientific directions as they emerge.