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

描述（由申请人提供）：将建立哈佛/波士顿/普罗维登斯临床试验单位（CTU），开展临床试验，以解决四个NIAID艾滋病毒临床研究网络的研究领域：艾滋病毒感染疫苗（HVTN）；艾滋病毒综合预防战略；杀菌剂艾滋病毒预防战略；成人艾滋病毒治疗策略，包括艾滋病毒治愈、非传染性合并症管理以及病毒性肝炎和结核病（ACTG）的传染性合并症。CTU将由7个临床研究所（CRSs）组成，这些研究所将进行临床试验。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。反恐组将由三位经验丰富的私家侦探，Raphael Dolin， Kenneth Mayer和Daniel Kuritzkes，将包括非常有成就的CRS领导和合作调查人员。CTU将作为一个综合的、高度协作的实体，通过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，该过程基于已建立的绩效指标，以及CTU和CRSs领导层和员工之间的强有力沟通。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。反恐组有各种各样的可接触的研究对象，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，并与所在社区有良好的联系。CTU已经准备好开展高效、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促进进行跨越传统网络边界的研究，并将在新的科学方向出现时迅速作出反应。

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. RELEVANCE: The Harvard/Boston/Providence Clinical Trial Unit will carry out clinical trials that address major questions in HIV clinical research. The results of the studies will lead to major improvements in ways to treat and prevent HIV infection and related diseases.