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: 8968796
• 负责人: Raphael Dolin
• 金额: $ 305.47万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-01-15 至 2020-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8968796
• 关键词: AIDS clinical trial group; AIDS prevention; AIDS/HIV problem; Address; Adult; Affect; Area; Boston; Clinical Research; Clinical Trials; Clinical Trials Unit; Communication; Communities; Comorbidity; Conduct Clinical Trials; Data Quality; Decision Making; Disease; Dolin; Evaluation; General Hospitals; HIV; HIV Infections; Health; Hepatitis C; Hospitals; Institution; Israel; Laboratories; Lead; Leadership; Massachusetts; Medical center; National Institute of Allergy and Infectious Disease; Occupational activity of managing finances; Performance; Pharmacy facility; Population; Prevention strategy; Process; Research; Research Personnel; Resource Allocation; Resources; Structure; Therapeutic; Tuberculosis; Vaccines; Viral hepatitis; Woman; base; clinical research site; experience; microbicide; prevent; response

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.

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）进行临床试验，以解决四个NIAID HIV HIV临床研究网络的研究领域：针对HIV感染的疫苗（HVTN）；综合艾滋病毒预防策略（HPTN）；微生物艾滋病毒预防策略（MTN）；和成人艾滋病毒治疗策略，包括艾滋病毒治疗，非感染的合并症管理以及病毒性肝炎和结核病的传染性合并症（ACTG）。 CTU将由将进行临床试验的机构的七个临床研究地点（CRS）组成。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，波士顿医疗中心和米里亚姆医院。 CTU将由三个经验丰富的PI，Drs领导。拉斐尔·多林（Raphael Dolin），肯尼斯·梅耶（Kenneth Mayer）和丹尼尔·库里兹克斯（Daniel Kuritzkes）将包括高度成就的CRS领导者和合作调查人员。 CTU将充当一个综合，高度协作的实体，该实体将通过有效的管理计划具有集中的计划，资源分配，决策和财务管理。决策将由严格的评估过程驱动，基于CTU和CRS的领导和员工之间的绩效和稳健沟通的既定指标。 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具有多种多样且可访问的研究人群，代表了受艾滋病毒/艾滋病，丙型肝炎病毒感染和结核病影响最大的社区，并且与与之基于的社区的社区建立了良好的联系。 CTU准备进行高效，高质量的临床试验，以解决HIV临床研究中的主要问题。它的领导力和行政结构将促进跨越传统网络边界的研究的进行，并在出现新科学方向的快速响应中。 相关性：哈佛/波士顿/普罗维登斯临床试验部门将进行临床试验，以解决HIV临床研究中的主要问题。研究的结果将导致治疗和预防艾滋病毒感染和相关疾病的方法的重大改善。