Quintiles Clinical Trial Unit for HIV/AIDS Clinical Trials Networks

项目概述：昆泰联邦服务公司（QFSI）是世界上最大的合同研究组织的一部分，提议创建和管理一个临床试验单位（CTU）来开展研究，以支持NIAID艾滋病毒/艾滋病临床试验网络的研究目标。CTU将参与三个高度优先的研究领域：转化研究/药物开发、临床管理优化和疫苗研发。在满负荷运转时，CTU将维持每月150名患者进行药物开发研究，每月110名患者进行临床管理优化，每月60名患者进行疫苗开发。QFSI将作为CTU的行政单位。费城、华盛顿、北弗吉尼亚、旧金山和洛杉矶的社区艾滋病毒护理站点将由经验丰富的研究人员领导，这些研究人员在招募大量患者（包括服务不足的人群）进行商业和社区临床试验并获得高质量数据方面具有良好的记录。危地马拉、洪都拉斯、哥斯达黎加和巴拿马的试验点将提供一个独特的机会，在艾滋病毒流行的前沿地区开展临床研究。这些中美洲站点的调查人员和工作人员受过高度训练，并致力于成为NIAID研究计划的组成部分。当地居民将受益于获得niaid资助的临床试验，中美洲的临床研究基础设施将蓬勃发展，这些研究的数据将推动临床科学的发展，为艾滋病毒感染者提供最佳护理。费城托马斯·杰斐逊大学的著名临床科学家凯瑟琳·斯奎尔斯博士将担任联合首席研究员，为CTU和网络领导组织之间提供科学联系，以便将研究与地点相匹配。相关性：随着全球艾滋病毒感染者人数的不断增加，迫切需要开发具有新型作用机制的强效抗艾滋病毒药物，这些药物对耐药艾滋病毒株有效，毒性较小且易于服用。此外，迫切需要更好地了解如何在疾病的不同阶段、不同患者群体以及有治疗经验与未治疗经验的个体中最好地使用现有药物。为了帮助临床试验网络解决这些问题，昆泰联合服务CTU将带来新的科学理念和新的患者群体。

DESCRIPTION (provided by applicant): Project Summary: Quintiles Federated Services, Inc. (QFSI), part of the world's largest contract research organization, proposes to create and administer a Clinical Trials Unit (CTU) to conduct studies to support the research objectives of the NIAID HIV/AIDS Clinical Trials Networks. The CTU will participate in three high-priority research areas: translational research/drug development, optimization of clinical management, and vaccine research and development. At full capacity, the CTU will maintain 150 patients/month on study in drug development, 110/month in optimization of clinical management, and 60/month in vaccine development. QFSI will serve as the CTU administrative unit. Community-based HIV care sites in Philadelphia, Washington (DC), northern Virginia, San Francisco, and Los Angeles will be led by highly experienced investigators with a proven track record of enrolling large numbers of patients (including underserved populations) into commercial and community-based clinical trials and obtaining high-quality data. Sites in Guatemala, Honduras, Costa Rica, and Panama will provide a unique opportunity to carry out clinical studies in an area that is a leading edge of the HIV pandemic. Investigators and staff at these Central American sites are highly trained and committed to becoming an integral part of NIAID's research program. The local populations will benefit by having access to NIAID-sponsored clinical trials, the clinical research infrastructure in Central America will thrive, and data from such studies stand to advance the clinical science that underpins the optimal care of HIV-infected individuals. Dr. Kathleen Squires, a renowned clinical scientist at Thomas Jefferson University, in Philadelphia, will serve as the co-principal investigator to provide scientific liaison between the CTU and the Network Leadership organizations for matching studies with sites. Relevance: As the global number of individuals living with HIV continues to rise, there is an urgent need to develop potent anti-HIV drugs with novel mechanisms of action, that are active against drug-resistant HIV strains, and that are less toxic and easier to take. There is also an urgent need to better understand how to best use currently available drugs in different stages of disease, in different patient populations, and in treatment-experienced vs. treatment-naive individuals. To help the Clinical Trials Networks address these issues, the Quintiles Federated Services CTU will bring fresh scientific ideas and new patient populations. ADMINISTRATIVE COMPONENT: