IMPAACT INVESTIGATIONS FOR FUTURE STUDIES

对未来研究的影响调查

基本信息

批准号：
10083349
负责人：
BARBARA DRIVER
金额：
$ 100.05万
依托单位：
WESTAT, INC.
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-12-01 至 2021-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10083349
关键词：
AIDS prevention Adolescent Anti-Retroviral Agents Area Child Clinical Trials Clinical Trials Network Collaborations Communities Development Equipment Formulation Foundations Funding Future Goals Grant HIV HIV Infections Human Resources Infant Institution International Aspects International Maternal Pediatric Adolescent AIDS Clinical Trials Intervention Investigation Leadership Light Monitor National Institute of Allergy and Infectious Disease National Institute of Child Health and Human Development Opportunistic Infections Postpartum Women Pregnant Women Prevention Protocols documentation Request for Proposals Research Research Personnel Research Priority Resources Science Services Site Specific qualifier value Symptoms Therapeutic Agents U-Series Cooperative Agreements Vaccines Work base co-infection follow-up knowledge base perinatal HIV pregnant prevent targeted treatment transmission process young woman

项目摘要

BACKGROUND and INTRODUCTION The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) provides clinical trial sites to the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT). The IMPAACT network is a cooperative group of institutions, investigators, and other collaborators focused on prevention and treatment of HIV infection and its related symptoms and co-infections in infants, children, adolescents and pregnant women. IMPAACT network activities are funded through Grants/Cooperative agreements sponsored by NIAID and co-funded by NICHD. The IMPAACT network and its leadership group, which includes NICHD, are responsible the creation of all their studies, protocols, and clinical trials. The IMPAACT Network goal is to conduct high quality clinical trials and/or protocols that advance the prevention and treatment of HIV and its complications for infants, children, adolescents, and pregnant/postpartum women globally. The IMPAACT research agenda includes four specific aims, which reflect its key areas of work. Those areas are HIV Treatment, HIV Prevention, HIV Cure, and HIV Complications. For each area, a Scientific Committee composed of experts in the specific field, site investigators, community representatives, and representatives of the central network resources, continually reassesses the research priorities in light of emerging science as well as new ideas and opportunities; seeks collaboration with other trials networks and research entities; oversees the formulation and review of study concept plans based on the scientific priorities; and monitors the development and implementation of approved network studies in its specific research area. NICHD collaboration with NIAID sponsored HIV research networks began in 1990, expanding clinical trial availability across NICHD funded clinical trial centers/sites. This collaboration helped make possible clinical trials by the IMPAACT Network to further evaluate antiretroviral therapeutic agents, other therapies targeted at opportunistic infections, and interventions to prevent perinatal HIV transmission. More recently the collaboration has expanded to evaluate potential HIV cure approaches and vaccines. In May 2019 the IMPAACT Network issued a Request for Proposals entitled “Investigations Needed for Future Clinical Trials and Secondary/Exploratory Study Objectives” with a primary purpose to encourage and support investigations that contribute to the knowledge base necessary for future clinical trials within the network’s research agenda. Investigators were invited to submit proposals for funding work that could be completed by 30 October 2020. That work must be 1) associated with secondary or exploratory study objectives specified in selected IMPAACT studies that closed to follow-up within the last five years and for which the primary analyses have been completed or 2) associated with completed non-network studies (with appropriate permissions). Priority was given to investigations considered foundational for future clinical trials within the network’s research agenda. SCOPE AND OBJECTIVES This Task Order will provide all necessary services, qualified personnel, materials, equipment, and facilities needed to implement, support, and conduct specified study proposals approved under the IMPAACT Network May 2019 RFP “Investigations Needed for Future Clinical Trials and Secondary/Exploratory Study Objectives”, in coordination with overall activities of the IMPAACT network. The overall objective of this effort is to complete the specified IMPAACT network approved investigations. The results of these projects are intended to expand the knowledge base necessary for future clinical trials and secondary or exploratory study objectives, the primary purpose of which is to contribute to the knowledge base necessary for future clinical trials within the network’s research agenda. These investigations are intended to be completed within approximately 12 months.

背景和简介尤尼斯·肯尼迪·施赖弗国家儿童健康和人类发展研究所 (NICHD) 为国际孕产妇儿科青少年艾滋病临床试验网络 (IMPAACT) 提供临床试验场所。婴儿、儿童、青少年和孕妇艾滋病毒感染及其相关症状和合并感染的预防和治疗通过NIAID和NIAID赞助的赠款/合作协议获得资助。由 NICHD 共同资助的 IMPAACT 网络及其领导小组（包括 NICHD）负责创建其所有研究、方案和临床试验。 IMPAACT 网络的目标是开展高质量的临床试验和/或方案，以促进全球婴儿、儿童、青少年和孕妇/产后妇女的艾滋病毒及其并发症的预防和治疗。IMPAACT 研究议程包括四个具体目标，即：这些领域包括艾滋病毒治疗、艾滋病毒预防、艾滋病毒治愈和艾滋病毒并发症。每个领域都有一个由特定领域的专家、现场调查员、社区代表和中央网络代表组成的科学委员会。资源，不断根据新兴科学以及新的想法和机会重新评估研究优先事项；寻求与其他试验网络和研究实体的合作；根据科学优先事项监督研究概念计划的制定和审查； NICHD 与 NIAID 赞助的 HIV 研究网络的合作始于 1990 年，扩大了 NICHD 资助的临床试验中心/站点的临床试验可用性，这一合作有助于通过 IMPAACT 网络进行临床试验以进一步评估。最近，合作范围已扩大到评估潜在的艾滋病毒治疗方法和疫苗。 2019 年 5 月，IMPAACT 网络发布了题为“未来临床试验和次要/探索性研究目标所需的调查”的提案征集，其主要目的是鼓励和支持为网络研究中未来临床试验所需的知识库做出贡献的调查邀请研究人员提交可在 2020 年 10 月 30 日之前完成的资助工作提案。该工作必须 1) 与次要或探索性相关。选定的 IMPAACT 研究中指定的研究目标，这些研究在过去五年内结束了随访，并且初步分析已经完成，或者 2) 与已完成的非网络研究相关（具有适当的许可）。用于网络研究议程内的未来临床试验。范围和目标该任务令将提供实施、支持和开展 IMPAACT 网络 2019 年 5 月 RFP“未来临床试验和治疗所需的调查”批准的特定研究提案所需的所有必要服务、合格人员、材料、设备和设施。次要/探索性研究目标”，与 IMPAACT 网络的整体活动相协调。这项工作的总体目标是完成已批准的指定 IMPAACT 网络调查。这些项目的结果旨在扩展未来临床试验和次要或探索性研究目标所需的知识库，其主要目的是为网络研究议程中未来临床试验所需的知识库。这些调查预计在大约 12 个月内完成。