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: 7938186
• 负责人: MARY BETH CULLEN
• 金额: $ 400万
• 依托单位: THE EMMES COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-29 至 2016-07-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7938186
• 关键词: BEST; PHARMACEUTICALS; CHILDREN; ACT; DATA

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. Specific Aims: 1. To develop and maintain administrative, technical, and analytical resources that integrate and coordinate the operations of all PODS Centers in performing studies of drugs for pediatric indications, to report to the NICHD any breaches in integration or coordination when they are identified, and to propose and execute a corrective plan of action under the oversight and guidance of the NICHD Project Officer and Contracting Officer. 2. To meet all the regulatory and reporting requirements of the FDA and the NICHD for each drug indication studied at the PODS Centers. 3. To facilitate communications among PODS Centers, the FDA and the NICHD. 4. To ensure that pediatric clinical trials are performed and documented according to the Good Clinical Practice (GCP) standards as described by the FDA and the International Conference on Harmonization Good Clinical Practice Guidelines. 5. To ensure the PODS Centers maintain current certified IRB approval of all federally funded protocols. 6. To design and maintain an adverse events reporting system with timely notification of NICHD and FDA of any and all adverse events 7. To ensure the accuracy of adverse events reporting, adherence to study protocols and timelines across the participating sites with timely notification of adverse events, and to rectify breaches in adherence to study protocols and inability or failure to meet deadlines in a timely fashion. 8. To monitor the quality of data gathering, data entry, and data analysis and report deficits in data quality, data entry and data analysis to NICHD in monthly reports. 9. To develop and maintain information systems for specified tasks. 10. To develop and maintain a pharmacy program to purchase, label and distribute drugs to the PODS Centers in accordance with FDA and NIH rules and guidelines. 11. To monitor performance of the different PODS Centers measured by predetermined performance standards established by the NICHD. 12. To assist NICHD and the PODS Centers with the identification of potential new PODS Centers, as necessary under the guidance of the NICHD, based on concerns about data quality, rate of participant recruitment, or other issues identified to, or by the NICHD. 13. Conduct preclinical toxicology studies, as necessary with the concurrence of NICHD. 14. To establish and maintain a database of all studies performed under the BPCA that can be used for research, regulatory and reporting purposes as directed by the NICHD. 15. Preparation of data and analysis for submission to the FDA for drug and patient audit that contains patient identifiers as well as redacted data that will be published in the FDA docket, and in peer-reviewed publications under guidance and review of the NICHD. 16. To establish and maintain a Data and Safety Monitoring Board (DSMB) and all necessary documentation of its activities and deliberations under the guidance of the NICHD to ensure the safety and welfare of the patients enrolled in the various trials and to ensure that all trials are conducted according to the highest scientific and ethical standards.

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》，该法案于2007年重新授权。NICHD负责对儿童使用但缺乏足够的儿科标签的优先、非专利药物的临床试验。排雷中心的责任包括行政活动和支持，以及协调支持和参与BPCA活动的其他IC。2003年，NICHD向宾夕法尼亚州费城的Premier Research授予了一份为期五(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。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、协调和管理将进行儿童药理学研究的多地点临床中心网络。 具体目标： 1.开发和维护行政、技术和分析资源，以整合和协调所有吊舱中心在进行儿科适应症药物研究方面的业务，在发现任何违反整合或协调的情况时向NICHD报告，并在NICHD项目干事和合同干事的监督和指导下提出和执行纠正行动计划。2.满足FDA和NICHD对PODS中心研究的每个药物适应症的所有监管和报告要求。3.促进豆荚中心、FDA和NICHD之间的沟通。4.确保儿科临床试验按照FDA和国际协调会议良好临床实践指南所述的良好临床实践(GCP)标准进行和记录。5.确保吊舱中心保持当前经认证的IRB对所有联邦资助方案的批准。6.设计和维护不良事件报告系统，及时向NICHD和FDA通报任何和所有不良事件7.确保不良事件报告的准确性，遵守各参与地点的研究方案和时间表，及时通知不良事件，并按照研究方案纠正违规行为，以及无法或未能及时赶上最后期限。8.监测数据收集、数据录入和数据分析的质量，并在月报中向排雷中心报告数据质量、数据录入和数据分析方面的不足。9.为特定任务开发和维护信息系统。10.根据FDA和NIH的规则和指南，制定和维护一个药房计划，以采购、标记药物并将其分发到Pods中心。11.监测不同豆荚中心的业绩，这些业绩是按照排雷中心制定的预定业绩标准衡量的。12.在排雷中心的指导下，根据对数据质量、参与者招聘率或向排雷中心或由排雷中心确定的其他问题的关切，协助排雷中心和可持续发展中心在必要时确定潜在的新的可持续发展中心。13.必要时在NICHD同意下进行临床前毒理学研究。14.建立和维护根据《生物多样性公约》进行的所有研究的数据库，该数据库可用于研究、监管和报告目的，如《防止酷刑公约》所述。15.准备数据和分析，以提交给FDA进行药物和患者审计，其中包含患者身份以及编辑后的数据，这些数据将在FDA的摘要中以及在NICHD的指导和审查下的同行评议出版物中公布。16.设立和维持一个数据和安全监测委员会，并在排雷中心的指导下，对委员会的活动和审议情况进行一切必要的记录，以确保参加各种试验的患者的安全和福利，并确保所有试验都按照最高的科学和道德标准进行。