PEDIATRIC OFF-PATENT DRUGS STUDY (PODS)

NICHD受美国国立卫生研究院委托，负责执行 国会授权的2002年儿童最佳药品法案，AS 2007年重新授权。NICHD负责履行以下职责 儿童优先使用的非专利药物的临床试验 但这缺乏足够的儿科标签。NICHD的职责包括 行政活动以及支持，并协调支持和 其他IC参与BPCA的活动..2003年，NICHD授予 与宾夕法尼亚州费城高级研究中心签订五(5)年合同，以提供 为BPCA数据协调中心(DCC)提供服务。该计划的目的是 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。这个DCC的功能是 提供法规、技术(包括统计和信息 技术)、行政和后勤支持以维护、协调 并管理多站点临床中心网络，该网络将进行 儿童的药理学研究。

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.