PEDIATRIC OFF-PATENT DRUGS STUDY (PODS)

儿科非专利药物研究 (PODS)

• 批准号: 8329190
• 负责人: MARA KUMMINS
• 金额: $ 5.7万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-30 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8329190
• 关键词: Award; Best Pharmaceuticals for Children Act; Child; Childhood; Clinical; Clinical Trials; Contracts; Data Coordinating Center; Drug usage; Information Technology; Label; Legal patent; Lorazepam; National Institute of Child Health and Human Development; Performance; Pharmaceutical Preparations; Pharmacology; Philadelphia; Research; Research Infrastructure; Services; Site; Status Epilepticus; United States National Institutes of Health

The NICHD, as delegated by the NIH, is responsible for implementing the Congressionally-mandated Best Pharmaceuticals for Children Act of 2002, as reauthorized in 2007. The NICHD is responsible for the performance of clinical trials of priority, ¿off patent¿ drugs that are used in children but that lack sufficient pediatric labeling. NICHD responsibility includes administrative activities as well as support, and coordinating support and participation of other ICs in BPCA activities.. In 2003, NICHD awarded a five (5) year contract to Premier Research of Philadelphia PA to provide services for a BPCA Data Coordinating Center (DCC). The purpose of the contract is to establish and support an infrastructure for the coordination of the BPCA pediatric clinical trials. The function of this DCC is to provide regulatory, technical (including statistical and information technology), administrative and logistical support to maintain, coordinate and manage a multi-site network of clinical centers which will conduct pharmacology studies in children.

NICHD受NIH委托，负责实施 2002年国会授权的儿童最佳药物法案， 2007年重新授权。NICHD负责执行 优先临床试验，用于儿童的非专利药物 但缺乏足够的儿科标签。NICHD的职责包括 行政活动以及支助和协调支助， 其他国际中心参与BPCA的活动。2003年，NICHD授予了 与宾夕法尼亚州费城的Premier Research签订五（5）年合同， BPCA数据协调中心（DCC）。的目的 合同是建立和支持协调的基础设施， BPCA儿科临床试验的结果该DCC的功能是 提供监管、技术（包括统计和信息 技术）、行政和后勤支助，以维持、协调 并管理一个多站点的临床中心网络， 儿童药理学研究。