The District of Columbia Clinical Trials Unit (DC CTU)

哥伦比亚特区临床试验单位 (DC CTU)

• 批准号: 10530587
• 负责人: Sarah Henn
• 金额: $ 179.15万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-01 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10530587
• 关键词: AIDS clinical trial group; AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Adult; Affect; African American population; Area; Behavioral; Capital; Caring; Clinic; Clinical; Clinical Trials; Clinical Trials Network; Clinical Trials Unit; Communicable Diseases; Communities; Conduct Clinical Trials; County; Data; Development; District of Columbia; Enrollment; Ensure; Epidemic; Epidemiologist; Funding; Geography; Goals; Growth; HIV; HIV prevention trials network; HIV/AIDS; Health; Infrastructure; Institution; Laboratories; Leadership; Longitudinal Studies; Maryland; Medical; Mentors; Methods; Mission; Modeling; National Institute of Allergy and Infectious Disease; Participant; Performance; Persons; Pharmacy facility; Population; Prevalence; Prevention; Research; Research Personnel; Resources; Risk; Sampling; Science; Services; Site; Therapeutic; Training; United States; United States National Institutes of Health; Universities; Washington; clinical research site; cohort; community engagement; data submission; design; experience; innovation; multidisciplinary; participant retention; participant safety; patient engagement; recruit; retention rate

Project Summary The District of Columbia Clinical Trials Unit (DC CTU) will conduct clinical trials for persons with and at risk for HIV in DC, where 1.8% of the overall population and 2.7% of the African-American population are living with HIV. The DC CTU will unite two existing, high-performing DAIDS/NIAID Clinical Research Sites (CRS), the Whitman-Walker Health CRS and the George Washington University CRS, in a new CTU, participating in the HIV/AIDS Adult Therapeutics and HIV Prevention Clinical Trials Networks. Our innovative and geographically- focused DC CTU will ensure exemplary clinical trials management, recruitment, and retention of a diverse sample of participants, with a community engagement strategy built on existing partnerships and Good Participatory Practices. The DC CTU will achieve four specific aims: 1) Provide scientific leadership and administrative infrastructure to allow high-quality conduct of therapeutic and prevention studies at two established CRSs; 2) Implement best practices to ensure continued high recruitment and retention rates; participant safety; and laboratory, pharmacy, data, and regulatory excellence; 3) Actively engage with the local community to ensure optimal enrollment of diverse participants from within and beyond clinic settings using Good Participatory Practices; and 4) Capitalize on the resources available from the DC CFAR and DC Cohort to engage senior investigators, mentor investigators in clinical trials conduct, and access a broad array of services to address NIH and network scientific and programmatic priorities. The DC CTU will engage participants who can benefit from innovative clinical trials while we contribute to high-quality participatory research that will eventually end the HIV epidemic.

项目摘要 哥伦比亚特区临床试验单位（DC CTU）将对患有或有风险的患者进行临床试验。 艾滋病毒在华盛顿特区，其中1.8%的总人口和2.7%的非洲裔美国人的人口生活在 艾滋病。DC CTU将合并两个现有的高性能DAIDS/NIAID临床研究中心（CRS）， 惠特曼-沃克健康CRS和乔治华盛顿大学CRS，在一个新的CTU，参与 艾滋病毒/艾滋病成人治疗和艾滋病毒预防临床试验网络。我们的创新和地理- 专注的DC CTU将确保示范性的临床试验管理，招募和保留多样化的 参与者样本，社区参与战略建立在现有的伙伴关系和良好的 预防性做法。DC CTU将实现四个具体目标：1）提供科学领导， 行政基础设施，以便在两个国家进行高质量的治疗和预防研究 （2）实施最佳做法，以确保继续保持较高的征聘率和保留率; 参与者安全;实验室，药房，数据和监管卓越; 3）积极与当地 社区，以确保最佳的参与者从内部和外部诊所设置使用 良好的预防性做法;以及4）利用发展中国家经常性财务报告和发展中国家群组提供的资源 聘请高级研究人员，指导研究人员进行临床试验，并获得广泛的 服务，以解决国家卫生研究院和网络的科学和方案的优先事项。华盛顿反恐组会介入 参与者可以从创新的临床试验中受益，同时我们为高质量的参与性研究做出贡献。 最终将终结艾滋病流行的研究