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

哈佛/波士顿/普罗维登斯临床试验中心 (Harvard/B/P CTU)

• 批准号: 10166336
• 负责人: Raphael Dolin
• 金额: $ 90万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-15 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10166336
• 关键词: 2019-nCoV; AIDS clinical trial group; AIDS prevention; AIDS/HIV problem; Address; Administrative Supplement; Adult; Affect; Animal Model; Antiviral Agents; Area; Boston; COVID-19; COVID-19 vaccine; Charge; Clinical Research; Clinical Trials; Clinical Trials Unit; Communication; Communities; Conduct Clinical Trials; Data; Decision Making; Development; Disease; Dolin; Evaluation; General Hospitals; HIV; HIV Infections; HIV Vaccine Trials Network; Health; Hepatitis C; Hospitals; Hot Spot; Hydroxychloroquine; Infection; Institution; Interleukin-6; Israel; Laboratory Research; Leadership; Massachusetts; Measurement; Medical center; Monoclonal Antibodies; National Institute of Allergy and Infectious Disease; Natural History; New England; Occupational activity of managing finances; Pathogenicity; Performance; Pharmacy facility; Population; Preclinical Testing; Prevention; Prevention Measures; Prevention strategy; Principal Investigator; Process; Public Health; RNA; Research; Research Personnel; Resource Allocation; Resources; Serologic tests; Structure; Testing; Therapeutic; Tuberculosis; Vaccines; Viral; Viral hepatitis; Woman; base; cationic antimicrobial protein CAP 37; clinical research site; comorbidity; experience; in vitro Assay; inhibitor/antagonist; interest; medical countermeasure; prevent; remdesivir; response; support network; transmission process; vaccine candidate; vaccine development; vaccine evaluation

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).

哈佛/波士顿/普罗维登斯临床试验单元（H/B/P CTU） 行政补充（06/01/20-11/30/20） 项目摘要 哈佛/波士顿/普罗维登斯临床试验部（CTU）进行临床试验，以解决 三个NIAID HIV临床研究网络：针对HIV感染的疫苗（HVTN）；综合艾滋病毒 预防策略（HPTN）；和成人艾滋病毒治疗策略，包括艾滋病毒治疗，非 - 病毒性肝炎和结核病（ACTG）的传染性合并症和感染性合并症。 CTU是 在进行临床试验的机构中完成了五个临床研究地点（CRS）。这些 机构是贝丝以色列女执事医疗中心，马萨诸塞州综合医院，杨百翰和 妇女医院，芬威医疗中心和米里亚姆医院。 CTU由三个高度领导 经验丰富的主要调查员博士。拉斐尔·多林（Raphael Dolin 高度成就的CRS领导者和合作的调查员。 CTU充当一个集成的，高度的 协作实体，其集中计划，资源分配，决策和财务 通过有效的管理计划进行管理。决策是由严格的评估过程驱动的 基于既定的绩效指标， CTU和CRS。 CTU的集中资源包括临床研究实验室（CRL），一项研究 药房协调员（RPC），数据和质量管理计划以及社区参与核心。这 CTU拥有潜水员和可访问的研究人群，代表受艾滋病毒/艾滋病影响最大的社区， 丙型肝炎病毒感染和结核病，并与社区建立了良好的联系 他们是基于的。 CTU毒气良好，经验丰富，可以进行高效，高质量的临床试验 解决HIV临床研究中的主要问题。它的领导和行政结构有助于 进行跨越传统网络边界的研究，并能够快速回应新的 科学方向出现。 根据此行政补充申请，HBP CTU正在回应Niaid的特别通知 利益（NOSI）（非AI-20-031）解决严重急性呼吸系统综合征研究的需求 冠状病毒2（SARS-COV-2）和冠状病毒病2019（Covid-19）。尼亚德对 专注于病毒自然历史，致病性，传播以及开发/扩展的项目 医学对策和合适的动物模型，用于疫苗和治疗的临床前测试 反对SARS-COV-2/COVID-19。为了满足这种公共卫生的需求，NIAID支持 已收取网络作为COVID-19疫苗的赞助试验的焦点，并且 单克隆抗体（mAb），以防止获得SARS-COV-2，并增加 了解并建立Covid-19的治疗方法。 HBP CTU及其会员CRS与NIAID- 支持的网络。通过现有的领导和行政结构，HBP CTU被激活 并准备立即支持这些努力。 HBP CTU总部位于马萨诸塞州的波士顿，这是SARS-COV-2感染的“热点”， 2019冠状病毒病病例。 HBP CTU中毒良好，经验丰富，以支持这些新兴的研究需求 和利益。特别是，HBP CTU准备支持和实施扩展所需的研究 在我们的会员临床研究地点（CRS）的SAR-COV-2 RNA和血清学测试。 CTU也是 准备快速实施与Niaid有关解决SARS-COV-2的各个方面有关的其他研究 以及Covid-19-19研究，疫苗开发和临床试验，其他预防措施以及潜力 治疗。 CTU的研究可能包括：波士顿/新英格兰的SARS-COV-2的Seroepidemiology 区域;用Remdesivir和Hydroxychloroquine等抗病毒药治疗Covid-19；晚期处理 与抗IL-6抑制剂的共vid-19病例；候选疫苗和mAB的临床试验的进行 预防和/或疾病治疗；以及用于进行测量的体外测定 SARS-COV-2神经化的能力，可以区分效力，广度， 和耐用性。 HBP CTU政府将监督这些活动的扩展和实施 在我们的会员CRS和临床研究实验室（CRL）。