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: 10305642
• 负责人: Sarah Henn
• 金额: $ 240.61万
• 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/10305642
• 关键词: AIDS clinical trial group; AIDS prevention; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adult; Affect; African American population; Americas; Area; Behavioral; Capital; Caring; Clinic; Clinical; Clinical Research; 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; 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; Walkers; Washington; clinical research site; cohort; community engagement; data submission; design; experience; innovation; multidisciplinary; participant retention; participant safety; 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.

项目概要 哥伦比亚特区临床试验单位 (DC CTU) 将为患有该疾病或有风险的人进行临床试验 华盛顿特区的艾滋病毒感染者，占总人口的 1.8% 和非裔美国人的 2.7% 艾滋病病毒。 DC CTU 将联合两个现有的高性能 DAIDS/NIAID 临床研究中心 (CRS)，即 Whitman-Walker Health CRS 和乔治华盛顿大学 CRS 在一个新的 CTU 中参与 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- 专注于 DC CTU 将确保模范临床试验管理、招募和保留多样化的人才 参与者样本，以及建立在现有伙伴关系和良好基础上的社区参与策略 参与式实践。 DC CTU 将实现四个具体目标： 1) 提供科学领导和 行政基础设施，允许在两个国家进行高质量的治疗和预防研究 建立共同参考标准； 2) 实施最佳实践，确保持续的高招聘率和保留率； 参与者的安全；以及实验室、药房、数据和监管卓越； 3）积极融入当地 社区，以确保来自诊所内外的不同参与者的最佳注册，使用 良好的参与实践； 4) 利用 DC CFAR 和 DC Cohort 提供的资源 吸引高级研究人员，指导研究人员进行临床试验，并获得广泛的信息 解决 NIH 和网络科学和计划优先事项的服务。 DC CTU 将参与 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做出贡献 最终将结束艾滋病毒流行的研究。