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)

基本信息

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
项目类别：
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

项目摘要

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).

哈佛大学/波士顿/普罗维登斯临床试验中心 (H/B/P CTU) 行政补充（06/01/20-11/30/20）项目概要哈佛/波士顿/普罗维登斯临床试验单位 (CTU) 开展临床试验来解决以下研究领域三个 NIAID HIV 临床研究网络：HIV 感染疫苗 (HVTN)；预防策略（HPTN）；以及成人艾滋病毒治疗策略，包括艾滋病毒治疗、非感染性疾病管理传染性合并症以及病毒性肝炎和结核病的传染性合并症 (ACTG)。由进行临床试验的机构的五个临床研究中心 (CRS) 组成。机构包括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由三位高层领导。经验丰富的首席研究员 Raphael Dolin 博士、Kenneth Mayer 博士和 Daniel Kuritzkes 博士，包括 CTU 的职能是高度综合的、高度集成的 CRS 领导者和合作调查员。集中规划、资源配置、决策、财务的协作实体通过有效的管理计划进行管理。决策由严格的评估流程驱动。基于既定的绩效指标以及领导层和员工之间的密切沟通 CTU 和 CRS 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。 CTU 拥有多样化且易于研究的人群，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，并与当地社区有良好的联系 CTU 准备充分且经验丰富，能够开展高效、高质量的临床试验。其领导和管理结构有利于解决艾滋病毒临床研究中的重大问题。进行跨越传统网络边界并能够快速响应新网络的研究科学方向的出现。根据本行政补充申请，HBP CTU 正在回应 NIAID 的特别通知兴趣 (NOSI) (NOT-AI-20-031) 以满足严重急性呼吸综合征研究的需要 NIAID 对冠状病毒 2 (SARS-CoV-2) 和 2019 冠状病毒 (COVID-19) 特别感兴趣。重点关注病毒自然史、致病性、传播的项目以及开发/扩展的项目用于疫苗和疗法临床前测试的医学对策和合适的动物模型为了解决这一紧迫的公共卫生需求，NIAID 支持了针对 SARS-CoV-2/COVID-19 的研究。网络已被任命为 COVID-19 疫苗和赞助试验的焦点单克隆抗体 (mAb) 用于防止感染 SARS-CoV-2，并增加了解并制定针对 COVID-19 的治疗方法。 HBP CTU 及其附属 CRS 与 NIAID 建立了良好且富有成效的关系通过其现有的领导和管理结构，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波士顿，这里一直是 SARS-CoV-2 感染的“热点”， HBP CTU 已准备好并拥有丰富的经验来支持这些新兴的研究需求。特别是，HBP CTU 准备支持和实施扩展所需的研究。我们的附属临床研究中心 (CRS) 还进行 SAR-CoV-2 RNA 和血清学检测。准备快速实施与 NIAID 负责解决 SARS-CoV-2 各个方面问题相关的其他研究和 COVID-19 研究、疫苗开发和临床试验、其他预防措施以及潜在的 CTU 的研究可能包括：波士顿/新英格兰地区 SARS-CoV-2 的血清流行病学。使用瑞德西韦和羟氯喹等抗病毒药物治疗 COVID-19；使用抗 IL-6 抑制剂治疗 COVID-19 病例；对候选疫苗和单克隆抗体进行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，能够区分效力、广度、 HBP CTU 管理部门将监督这些活动的扩展和实施。在我们附属的 CRS 和临床研究实验室 (CRL)。