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

哈佛/波士顿/普罗维登斯临床试验单位（H/B/P CTU） 行政补充（20年6月1日至20年11月30日） 项目摘要 哈佛/波士顿/普罗维登斯临床试验单位（CTU）进行临床试验，以解决以下研究领域： 三个NIAID艾滋病毒临床研究网络：艾滋病毒感染疫苗（HVTN）;综合艾滋病毒 预防策略（HPTN）和成人艾滋病毒治疗策略，包括艾滋病毒治愈，非艾滋病毒感染者的管理， 感染性共病和病毒性肝炎和结核病（ACTG）的感染性共病。职工盟 由进行临床试验的机构的五个临床研究中心（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，布里格姆和 妇女医院，芬威健康中心和米里亚姆医院。反恐组由三个高层领导 经验丰富的主要研究者，Raphael Dolin博士，Kenneth Mayer和丹尼尔Kuritzkes，包括 非常有成就的CRS领导者和合作调查员。反恐组是一个高度整合的 协作实体，它具有集中的规划，资源分配，决策和财务 通过有效的管理计划进行管理。决策由严格的评估过程驱动 根据既定的业绩衡量标准以及联合国系统领导层和工作人员之间的有力沟通， CTU和CRS CTU的集中资源包括临床研究实验室（CRL）、研究中心、 药房协调员（RPC），数据和质量管理计划，以及社区参与核心。的 CTU拥有多样化和可访问的研究人群，代表受艾滋病毒/艾滋病影响最严重的社区， 丙型肝炎病毒感染和结核病，并与社区有着良好的联系， 他们所依据的。CTU准备充分，经验丰富，可以进行高效，高质量的临床试验 解决艾滋病毒临床研究中的主要问题。其领导和行政结构有助于 开展跨越传统网络边界的研究，并对新的 科学的方向，因为他们出现。 根据这一行政补充申请，HBP CTU正在回应NIAID的特别通知， 关注（NOSI）（NOT-AI-20-031），以满足对严重急性呼吸系统综合症研究的需求 冠状病毒2（SARS-CoV-2）和冠状病毒疾病2019（COVID-19）。NIAID特别感兴趣的是 关注病毒自然史、致病性、传播的项目，以及正在开发/扩大的项目 疫苗和治疗药物临床前试验的医学对策和合适的动物模型 针对SARS-CoV-2/COVID-19。为了满足这一紧迫的公共卫生需求，NIAID支持 网络已被指控作为COVID-19疫苗赞助试验的协调中心， 单克隆抗体（mAb）用于预防SARS-CoV-2的获得，以及增加 了解COVID-19并建立治疗方法。 HBP CTU及其附属的CRS与NIAID建立了良好和富有成效的关系- 支持的网络。通过其现有的领导和行政结构， 并准备立即支持这些努力。 HBP CTU位于马萨诸塞州的波士顿，那里一直是SARS-CoV-2感染的“热点”， 新冠肺炎病例。HBP CTU准备充分，经验丰富，以支持这些新兴的研究需求 和兴趣。特别是，HBP CTU准备支持和实施扩大 在我们的附属临床研究中心（CRS）进行SAR-CoV-2 RNA和血清学检测。反恐组也是 准备迅速实施与NIAID负责的其他研究，以解决SARS-CoV-2的所有方面 和COVID-19研究，疫苗开发和临床试验，其他预防措施，以及潜在的 治疗。CTU的研究可能包括：波士顿/新英格兰SARS-CoV-2的血清流行病学 地区;用抗病毒药物治疗COVID-19，如瑞德西韦和羟氯喹;治疗晚期 使用抗IL-6抑制剂的COVID-19病例;进行候选疫苗和mAb的临床试验， 疾病的预防和/或治疗;以及用于进行测量的体外测定的开发 SARS-CoV-2中和，有能力区分效力，广度， 和耐久性。住房和银行业务股行政部门将监督这些活动的扩大和实施 在我们的附属CRS和临床研究实验室（CRL）。

Harvard/Boston/Providence Clinical Trials Unit (H/B/P CTU) Administrative Supplement (06/01/20-11/30/20) PROJECT SUMMARY The Harvard/Boston/Providence Clinical Trials Unit (CTU) conducts clinical trials to address research areas of three NIAID HIV Clinical Research Networks: vaccines against HIV infection (HVTN); integrated HIV prevention strategies (HPTN); 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 is comprised of five clinical research sites (CRSs) at institutions where the clinical trials are conducted. These institutions are Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Brigham and Women’s Hospital, Fenway Health Center, and The Miriam Hospital. The CTU is led by three highly experienced principal investigators, Drs. Raphael Dolin, Kenneth Mayer and Daniel Kuritzkes, and includes highly accomplished CRS leaders and collaborating investigators. The CTU functions as an integrated, highly collaborative entity, which has centralized planning, resource allocation, decision-making and financial management through an efficient administration plan. Decisions are 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 (CRL), a Research Pharmacy Coordinator (RPC), 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 and experienced to carry out efficient, high quality clinical trials to address major questions in HIV clinical research. Its leadership and administrative structure facilitates the conduct of studies which cross traditional network boundaries and that enables rapid responses to new scientific directions as they emerge. Under this Administrative Supplement application, The HBP CTU is responding to NIAID’s Notice of Special Interest (NOSI) (NOT-AI-20-031) to address the need for research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19). NIAID is particularly interested in projects focusing on viral natural history, pathogenicity, transmission, as well as projects developing/expanding medical countermeasures and suitable animal models for pre-clinical testing of vaccines and therapeutics against SARS-CoV-2/COVID-19. In order to address this urgent public health need, the NIAID-supported networks have been charged to serve as a focal point of sponsored trials in COVID-19 vaccines and monoclonal antibodies (mAbs) for preventing the acquisition of SARS-CoV-2, as well as to increase understanding of and to establish treatments for COVID-19. The HBP CTU and its affiliated CRSs have well established and highly productive relationships with the NIAID- supported networks. Through its existing leadership and administrative structure, the HBP CTU is activated and prepared to immediately support these efforts. The HBP CTU is based in Boston, Massachusetts, which has been a “hot spot” for SARS-CoV-2 infections and COVID-19 cases. The HBP CTU is well poised and experienced to support these emerging research needs and interests. In particular, HBP CTU is prepared to support and implement studies needed for expanded SAR-CoV-2 RNA and serology testing at our affiliated Clinical Research Sites (CRSs). The CTU is also prepared to rapidly implement other studies related to NIAID’s charge to address all aspects of SARS-CoV-2 and COVID-19 research, vaccine development and clinical trials, other prevention measures, and potential treatments. Studies at the CTU may include: seroepidemiology of SARS-CoV-2 in the Boston/New England area; treatment of COVID-19 with antivirals such as remdesivir and hydroxychloroquine; treament of advanced cases of COVID-19 with anti-IL-6 inhibitors; the conduct of clinical trials of candidate vaccines and mAbs for prevention and/or treatment of disease; and the development of in vitro assays used for making measurements of SARS-CoV-2 neutralization, which have the ability to distinguish incremental advances in potency, breadth, and durability. The HBP CTU administration will oversee the expansion and implementation of these activities at our affiliated CRSs and Clinical Research Laboratories (CRLs).