PEDIATRIC OFF-PATENT DRUGS STUDY (PODS)

儿科非专利药物研究 (PODS)

• 批准号: 7902732
• 金额: $ 41.45万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-04-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7902732
• 关键词: PEDIATRIC; OFF; PATENT; DRUGS; STUDY

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受美国国立卫生研究院委托，负责执行国会授权的《2002年儿童最佳药品法》，该法案于2007年重新授权。NICHD负责对儿童使用但缺乏足够的儿科标签的优先、非专利药物的临床试验。排雷中心的责任包括行政活动和支持，以及协调支持和参与BPCA活动的其他IC。2003年，NICHD向宾夕法尼亚州费城的Premier Research授予了一份为期五(5)年的合同，为BPCA数据协调中心(DCC)提供服务。该合同的目的是建立和支持协调BPCA儿科临床试验的基础设施。DCC的职能是提供监管、技术(包括统计和信息技术)、行政和后勤支持，以维护、协调和管理将进行儿童药理学研究的多地点临床中心网络。