BEST PHARMACEUTICALS FOR CHILDREN ACT - DATA COORDINATING CENTER

最佳儿童药物法案 - 数据协调中心

• 批准号: 9325892
• 负责人: RAVINDER ANAND
• 金额: $ 120.14万
• 依托单位: THE EMMES COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-29 至 2017-07-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9325892
• 关键词: Area; Award; Best Pharmaceuticals for Children Act; Child; Childhood; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Complement; Conduct Clinical Trials; Consultations; Contractor; Contracts; Data; Data Coordinating Center; Data Quality; Data Storage and Retrieval; Devices; Discipline of obstetrics; Disease; Drug Kinetics; Drug usage; Good Clinical Practice; Guidelines; Individual; Institutes; International; Knowledge; Label; Leadership; Monitor; National Institute of Child Health and Human Development; Office for Human Research Protections; Pediatric Research; Pharmaceutical Preparations; Pharmacodynamics; Population; Process; Protocols documentation; Reporting; Research; Research Infrastructure; Research Personnel; Safety; Site; Statistical Data Interpretation; Statutes and Laws; Structure; Therapeutic; Therapeutic Uses; Time; Training; United States; United States Dept. of Health and Human Services; United States Food and Drug Administration; United States National Institutes of Health; Work; authority; base; clinical research site; data integration; data management; data sharing; drug development; improved; information gathering; pediatric pharmacology; pre-clinical; preclinical study; programs; protocol development; treatment strategy

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

《儿童最佳药品法案》提供了一种研究儿童专利药物和非专利药物的机制。 2002 年最初的 BPCA 指示卫生与公众服务部 (DHHS) 部长通过美国国立卫生研究院 (NIH) 主任制定儿科药物开发计划。 NIH 主任将建立和实施儿科药物开发计划的权力和责任授予尤尼斯·肯尼迪·施赖弗国家儿童健康和人类发展研究所 (NICHD) 所长。 BPCA 立法授权 NICHD， 与美国食品和药物管理局 (FDA) 以及儿科研究专家协商，以确定儿科疾病、失调或病症的治疗差距，其中更全面的治疗策略（包括药物和生物制剂）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部门 (OTTPB)，负责管理该研究计划（因此称为“ “BPCA 计划”），并与拥有重要儿科研究组合的其他 NIH 研究所和中心 (IC) 合作，以完成改善儿科治疗的任务。 NICHD 制定了一份需要在儿科实践中进一步研究的药物优先清单，并赞助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 个单独项目，以收集 改进儿童药物标签的信息。 NICHD 目前维护着合同基础设施，为各种 BPCA 活动。该基础设施需要与 NICHD 和 其他责任方从此称为承包商。这种结构，此后被称为“ 联盟”，共同构建、实施、监测和审核临床前和临床 活动，以提高对药物、生物制剂和设备的认识和标签 孩子们。以下为相关责任方