IMPAACT INVESTIGATIONS FOR FUTURE STUDIES

对未来研究的影响调查

• 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
• 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

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·施莱弗国家儿童健康和人类发展研究所(NICHD)为国际母儿青少年艾滋病临床试验网络(IMPAACT)提供临床试验场地。艾滋病毒/艾滋病综合防治网络是一个由机构、研究人员和其他合作者组成的合作小组，重点关注预防和治疗艾滋病毒感染及其相关症状和婴儿、儿童、青少年和孕妇的混合感染。该中心的网络活动通过赠款/合作协议提供资金，该协议由NIAID赞助，并由NICHD共同资助。IMPAACT网络及其领导小组，包括NICHD，负责创建他们的所有研究、方案和临床试验。 IMPAACT网络的目标是进行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/产后妇女预防和治疗艾滋病毒及其并发症。提高妇女地位委员会的研究议程包括四个具体目标，这些目标反映了其主要工作领域。这些领域是艾滋病毒治疗、艾滋病毒预防、艾滋病毒治疗和艾滋病毒并发症。对于每个领域，由特定领域的专家、现场调查人员、社区代表和中央网络资源的代表组成的科学委员会根据新兴科学以及新的想法和机会，不断重新评估研究优先事项；寻求与其他试验网络和研究实体合作；监督根据科学优先事项制定和审查研究概念计划；并监测其特定研究领域经批准的网络研究的发展和实施情况。NICHD与NIAID赞助的艾滋病毒研究网络的合作始于1990年，扩大了NICHD资助的临床试验中心/地点的临床试验可获得性。这一合作帮助IMPAACT网络进行了临床试验，以进一步评估抗逆转录病毒治疗药物、针对机会性感染的其他疗法以及预防围产期艾滋病毒传播的干预措施。最近，合作已扩大到评估潜在的艾滋病毒治愈方法和疫苗。 2019年5月，IMPAACT网络发布了一份题为“未来临床试验所需的调查和次级/探索性研究目标”的征求建议书，其主要目的是鼓励和支持有助于在该网络的研究议程内为未来临床试验提供必要知识库的调查。调查人员应邀就可在2020年10月30日前完成的供资工作提出建议。该工作必须1)与次要工作或探索性工作相关 在过去五年内结束后续行动并已完成初步分析的IMPAACT选定研究中规定的研究目标，或2)与已完成的非网络研究有关(经适当许可)。在该网络的研究议程中，优先考虑了被认为是未来临床试验的基础的调查。 范围和目标 本任务单将提供实施、支持和实施根据IMPAACT网络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。 次级/探索性研究目标“，与亚太区域中心网络的总体活动相协调。 这项工作的总体目标是完成指定的IMPAACT网络批准的调查。这些项目的结果旨在扩大未来临床试验和二级或探索性研究目标所需的知识库，其主要目的是在该网络的研究议程内为未来临床试验贡献必要的知识库。这些调查计划在大约12个月内完成。