PEDIATRIC OFF-PATENT DRUGS STUDY (PODS) BCPA

儿科非专利药物研究 (PODS) BCPA

• 批准号: 7902346
• 负责人: BERNARD BROWNSTEIN
• 金额: $ 41.87万
• 依托单位: PREMIER RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2009-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7902346
• 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 NIH 委托，负责实施国会授权的 2002 年儿童最佳药物法案，并于 2007 年重新授权。NICHD 负责对用于儿童但缺乏足够儿科标签的优先“非专利”药物进行临床试验。 NICHD 的职责包括行政活动以及支持、协调其他 IC 对 BPCA 活动的支持和参与。2003 年，NICHD 向费城 PA 的 Premier Research 授予了一份五 (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。该 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、协调和管理将在儿童中进行药理学研究的多站点临床中心网络。