PEDIATRIC OFF-PATENT DRUGS STUDY (PODS) BCPA

NICHD由NIH授权，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负责进行优先临床试验，即用于儿童但缺乏足够儿科标签的非专利药物。NICHD的职责包括行政活动以及支持和协调其他国际中心对BPCA活动的支持和参与。2003年，NICHD与宾夕法尼亚州费城的Premier Research签订了一份为期五年的合同，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基础设施，以协调BPCA儿科临床试验。本DCC的职能是提供法规、技术（包括统计和信息技术）、行政和后勤支持，以维护、协调和管理将在儿童中开展药理学研究的多中心临床中心网络。

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.