BEST PHARMACEUTICALS FOR CHILDREN ACT - DATA COORDINATING CENTER

《儿童最佳药品法》为研究儿童专利药物提供了一种机制。2002年最初的BPCA指示卫生与公众服务部(DHHS)秘书通过国家卫生研究院(NIH)主任行事，建立儿科药物开发计划。国立卫生研究院院长授权尤尼斯·肯尼迪·施莱弗国家儿童健康和人类发展研究所(NICHD)所长建立和执行儿科药物开发方案的权力和责任BPCA立法授权NICHD， 咨询食品和药物管理局(FDA)和儿科研究专家，以确定儿科疾病、障碍或条件下的治疗差距，在这些情况下，包括药物和生物制品在内的更全面的治疗策略知识可能对儿科人群有益。NICHD，特别是产科和儿科药理学和治疗学处(OTTPB)管理这项研究计划(因此被称为 BPCA计划)，并与其他拥有重要儿科研究组合的NIH研究所和中心(IC)合作，以完成改进儿科治疗的任务。NICHD制定了需要在儿科实践中进一步研究的优先药物清单，并赞助了这些优先治疗药物的临床试验。自BPCA于2002年成立以来，NICHD已授予约35个单独的项目以收集 改善儿童用药标签的信息。 NICHD目前维护着一个合同基础设施，为各种 BPCA活动。这一基础设施需要与NICHD和 因此，其他责任方被称为承包人。这种结构，从今往后被称为“ 联盟“，共同努力建立、实施、监测和审计临床前和临床 活动，以提高对药品、生物制品和器械的认识和标签 孩子们。以下是责任方

The Best Pharmaceuticals for Children Act provides a mechanism for studying on- and offpatent drugs in children. The original BPCA of 2002 directed the Secretary of the Department of Health and Human Services (DHHS), acting through the Director of the National Institutes of Health (NIH), to establish a program for pediatric drug development. The Director of the NIH delegated to the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) the authority and responsibility for establishment and conduct of a pediatric drug development programThe BPCA legislation authorizes the NICHD, in consultation with the Food and Drug Administration (FDA) and with experts in pediatric research, to identify therapeutic gaps in pediatric diseases, disorders or conditions in which more complete knowledge of treatment strategies, including drugs and biologics, may be beneficial to the pediatric population. The NICHD, specifically the Obstetric and Pediatric Pharmacology and Therapeutics Branch (OTTPB), administers the research program (hence forth termed the “BPCA Program”) and works cooperatively with other NIH Institutes and Centers (ICs) with significant pediatric research portfolios in order to fulfill the mandate to improve pediatric therapeutics. The NICHD develops a priority list of drugs needing further study in pediatric practice and sponsors the clinical trials of those prioritized therapeutics. Since the inception of the BPCA in 2002, the NICHD has awarded approximately 35 individual projects for the purpose of gathering information to improve labeling of drugs that are used in children. The NICHD currently maintains an infrastructure of contracts to provide support for various BPCA activities. This infrastructure requires a high level of interaction with the NICHD and the other responsible parties hence forth termed Contractors. This structure, henceforth termed “the Consortium”, work together to construct, implement, monitor and audit pre-clinical and clinical activities, in order to improve the knowledge and labeling of drugs, biologics and devices used in children. Below are the responsible parties