SUPPORT SERVICES FOR THE HIV AIDS CLINICAL TRIALS NETWORKS

HIV 艾滋病临床试验网络的支持服务

• 批准号: 10329826
• 负责人: BARBARA DRIVER
• 金额: $ 381.21万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-12-01 至 2021-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10329826
• 关键词: AIDS clinical trial group; Acquired Immunodeficiency Syndrome; Adolescent; Biological Assay; Childhood; Clinical; Clinical Trials; Clinical Trials Network; Conduct Clinical Trials; Diagnosis; Diagnostic Procedure; Disease; Ensure; Epidemiology; Equipment; Evaluation; Future; HIV; HIV Infections; Human Resources; Immunologics; Immunology procedure; International; International Maternal Pediatric Adolescent AIDS Clinical Trials; Investigational Therapies; Laboratories; Logistics; Maternal Health; Monitor; National Institute of Allergy and Infectious Disease; National Institute of Child Health and Human Development; Natural History; Performance; Pharmacology; Prevention; Prevention strategy; Protocols documentation; Research; Services; Site; Specific qualifier value; Specimen; Specimen Handling; Testing; Work; adolescent health; clinical center; insight; laboratory facility; patient population; virology

The Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD) requires continuous and recurring logistical, technical, and administrative support to maintain, coordinate, and manage a multi-site network of domestic and international clinical centers conducting research on treatment, prevention, diagnosis, epidemiology, and natural history of HIV infection and disease and its infectious and non-infectious complications in pediatric, adolescent, and maternal health patient populations. This Task Order will provide all the necessary services, qualified personnel, materials, equipment, and facilities needed to implement, maintain, coordinate, and manage a multi-site network of clinical centers to conduct clinical trials for evaluation of investigational therapies, diagnostic techniques, prevention strategies, epidemiology and natural history of multiple aspects of HIV infection in pediatric, adolescent, and maternal health patient populations. Support the clinical works in IMPAACT, ATN, ACTG, INSIGHT Networks. Ensure sites have access to laboratory facilities with capability to perform virologic, immunologic, pharmacologic, and other laboratory assays, specimen processing, and specimen storage specified by IMPAACT/ACTG/INSIGHT/ATN or other Network protocols in which NICHD clinical centers participate. Selected virologic and immunologic assays will require performance by a NIAID certified laboratory (such testing may be done at NIAID-certified laboratories that are NICHD Network sites or non-NICHD Network sites). Provide services for implementation and monitoring of multiple ongoing and future clinical trials in support of the IMPACCT, ACTG, INSIGHT, ATN Networks.

Eunice Kennedy Shriver国家儿童健康和人类发展研究所（NICHD）需要持续和经常性的后勤，技术和行政支持，以维护，协调和管理国内和国际临床中心的多站点网络，这些临床中心开展有关治疗，预防，诊断，流行病学和HIV感染和疾病及其感染性和非感染性并发症的自然史的研究。青少年和孕产妇健康患者人群。 本任务指令将提供实施、维护、协调和管理多中心临床中心网络所需的所有必要服务、合格人员、材料、设备和设施，以开展临床试验，评价儿科、青少年和孕产妇健康患者人群中HIV感染多个方面的研究性治疗、诊断技术、预防策略、流行病学和自然史。 支持IMPAACT、ATN、ACTG、INSIGHT网络的临床工作。 确保研究中心能够使用实验室设施，这些设施能够执行IMPAACT/ACTG/INSIGHT/ATN或NICHD临床中心参与的其他网络协议规定的病毒学、免疫学、药理学和其他实验室检测、标本处理和标本储存。选定的病毒学和免疫学检测将需要由NIAID认证的实验室进行（例如 测试可以在NIAID认证的实验室进行，这些实验室是NICHD网络站点或非NICHD网络站点）。 为IMPACCT、ACTG、INSIGHT、ATN网络提供支持，为正在进行和未来的多项临床试验的实施和监测提供服务。