Byramee Jeejeebhoy Medical College (BJMC), Pune, India: Clinical Trials Unit

Byramee Jeejeebhoy 医学院 (BJMC)，印度浦那：临床试验单位

• 批准号: 7096994
• 负责人: ROBERT C. BOLLINGER
• 金额: $ 10万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-20 至 2014-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7096994
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Area; Asia; Cancer Trials Support Unit; Caring; Child; Childhood; Clinic; Clinical; Clinical Management; Clinical Trials; Communities; Counseling; Enrollment; Epidemic; HIV; HIV Infections; India; Infant; Laboratories; Leadership; Medical; Mothers; Phase; Positioning Attribute; Pregnant Women; Prevention; Procedures; Randomized Clinical Trials; Research; Research Infrastructure; Research Institute; Research Personnel; Research Priority; Running; Testing; Trust; Universities; base; clinical research site; college; day; experience; follow-up; prevent; prevention clinical trial; programs; response; success; transmission process; treatment trial

DESCRIPTION (provided by applicant): The Indo-US collaborative research group, at the Byramjee Jeejeebhoy Medical College (BJMC) in Pune, India, is currently conducting the only NIH-sponsored; Phase III randomized clinical trial for prevention of mother-to-child HIV transmission (MTCT) in India. In response to this RFA, we propose a Clinical Trials Unit (CTU) with a single Clinical Research Site (CRS) that will build upon the success of our existing leadership, organization, clinical trials management procedures, as well as our experienced investigators and staff. Our CTU proposes to participate in trials that will address two research priority areas: 1) Prevention of MTCT and 2) Optimization of Clinical Management of HIV-infected Children. Johns Hopkins University (JHU) will be the primary grantee and will support the CTU leadership, administration, community activities and a single CRS in Pune, through two subcontracts (BJMC and ED SEARCH). BJMC will provide scientific and administrative leadership to the CTU, as well as clinical/laboratory infrastructure and clinical care support for the CRS. BJMC will also utilize the help of the National AIDS Research Institute for specialized laboratory support. ED SEARCH, a registered, Indian, non-profit Trust will provide scientific and administrative leadership, as well as day-to-day management of the CRS, regulatory requirements and good clinical practices. ED SEARCH will also manage support of our Community Advisory Board, as well as our trial recruitment program in 21 community-based clinics run by the Pune Municipal Corporation and the Pimpri Chinchwad Municipal Corporation. Our application reflects a fully-functional, experienced, actively-enrolling CTU that has more than three years of experience conducting the only Phase III HIV prevention clinical trial in India. We also have significant infrastructure, a proven GCP track record, and documented capacity for enrollment and retention of mothers and infants. Since August 2003, our CRS has provided HIV voluntary counseling and testing to more than 54,000 pregnant women in Pune. We have enrolled 593 HIV-infected mothers (20/month) in our current MTCT trial. Our capacity for pediatric treatment trials is supported by our active follow-up of 160 HIV-infected children and a supportive community-based referral program. The trajectory and impact of the global HIV epidemic is shifting to Asia and to India. Therefore, our CTU in Pune is uniquely positioned to contribute to the global efforts to prevent infant HIV infection and to optimize treatment of infected children. ADMINISTRATIVE COMPONENT:

描述（由申请人提供）： 位于印度浦那 Byramjee Jeejeebhoy 医学院 (BJMC) 的印美合作研究小组目前正在进行唯一一项由 NIH 资助的研究；印度预防艾滋病毒母婴传播（MTCT）的 III 期随机临床试验。为了回应此 RFA，我们提议建立一个具有单一临床研究中心 (CRS) 的临床试验单位 (CTU)，该中心将建立在我们现有领导、组织、临床试验管理程序以及经验丰富的研究人员和工作人员的成功基础上。我们的 CTU 提议参与涉及两个研究优先领域的试验：1) 预防母婴传播；2) 优化艾滋病毒感染儿童的临床管理。约翰·霍普金斯大学 (JHU) 将是主要受资助者，并将通过两个分包合同（BJMC 和 ED SEARCH）支持 CTU 的领导、管理、社区活动和位于浦那的单一 CRS。 BJMC 将为 CTU 提供科学和行政领导，并为 CRS 提供临床/实验室基础设施和临床护理支持。 BJMC 还将利用国家艾滋病研究所的帮助来提供专门的实验室支持。 ED SEARCH 是一家注册的印度非营利性信托公司，将提供科学和行政领导，以及 CRS 的日常管理、监管要求和良好的临床实践。 ED SEARCH 还将管理我们的社区咨询委员会的支持，以及我们在浦那市政府和 Pimpri Chinchwad 市政府运营的 21 个社区诊所的试验招募计划。我们的申请体现了一个功能齐全、经验丰富、积极招募的 CTU，该 CTU 拥有三年多在印度进行唯一的 III 期 HIV 预防临床试验的经验。我们还拥有重要的基础设施、经过验证的 GCP 跟踪记录以及记录在案的母婴注册和保留能力。自 2003 年 8 月以来，我们的 CRS 已为浦那 54,000 多名孕妇提供艾滋病毒自愿咨询和检测。我们已在当前的 MTCT 试验中招募了 593 名 HIV 感染母亲（20 名/月）。我们对 160 名 HIV 感染儿童的积极随访和基于社区的支持性转诊计划为我们的儿科治疗试验能力提供了支持。全球艾滋病毒流行的轨迹和影响正在转向亚洲和印度。因此，我们位于浦那的 CTU 具有独特的优势，可以为全球预防婴儿艾滋病毒感染和优化受感染儿童的治疗做出贡献。 行政部分：