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: 8919734
• 负责人: GREG DOYLE-WANDELL
• 金额: $ 359.06万
• 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/8919734
• 关键词: Adherence; Adverse event; Award; Best Pharmaceuticals for Children Act; Child; Childhood; Clinical; Clinical Practice Guideline; Clinical Trials; Clinical Trials Data Monitoring Committees; Communication; Contracts; Data; Data Analyses; Data Coordinating Center; Data Quality; Data Reporting; Databases; Documentation; Drug usage; Enrollment; Ensure; Ethics; Failure; Funding; Good Clinical Practice; Guidelines; Information Systems; Information Technology; Institutional Review Boards; International; Label; Legal patent; Measures; Monitor; National Institute of Child Health and Human Development; Notification; Participant; Patients; Peer Review; Performance; Pharmaceutical Preparations; Pharmacology; Pharmacy facility; Philadelphia; Preparation; Protocols documentation; Publications; Publishing; Reporting; Research; Research Infrastructure; Resources; Safety; Services; Site; Social Welfare; Specific qualifier value; System; TimeLine; Toxicology; United States National Institutes of Health; base; design; meetings; operation; pre-clinical; programs; symposium

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负责对用于儿童但缺乏足够儿科标签的优先“非专利”药物进行临床试验。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。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PODS中心在儿科适应症药物研究中的运作，向NICHD报告发现的任何整合或协调违规行为，并在NICHD项目官员和合同官员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中心研究的每种药物适应症的所有监管和报告要求。3.促进PODS中心、FDA和NICHD之间的沟通。4.确保儿科临床试验按照FDA和人用药品注册技术要求国际协调会药物临床试验质量管理规范（GCP）标准进行并记录。5.确保PODS中心保持对所有联邦资助方案的当前经认证IRB批准。6.设计和维护不良事件报告系统，及时通知NICHD和FDA任何和所有不良事件。确保不良事件报告的准确性，遵守研究方案和参与研究中心的时间表，及时通知不良事件，并及时纠正违反研究方案以及无法或未能遵守最后期限的情况。8.监测数据收集、数据输入和数据分析的质量，并在月度报告中向NICHD报告数据质量、数据输入和数据分析方面的缺陷。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，制定并维护一个药房计划，以购买、贴标签并向PODS中心分发药物。11.通过NICHD制定的预定绩效标准来监控不同PODS中心的绩效。12.协助NICHD和PODS中心识别潜在的新PODS中心，必要时在NICHD的指导下，基于对数据质量、受试者招募率或NICHD确定或确定的其他问题的关注。13.必要时在NICHD的同意下进行临床前毒理学研究。14.建立并维护根据BPCA进行的所有研究的数据库，该数据库可用于NICHD指导的研究、监管和报告目的。15.准备数据和分析，以提交给FDA进行药物和患者稽查，其中包含患者标识符以及将在FDA备审表中以及在NICHD指导和审查下的同行评审出版物中发表的编辑数据。16.在NICHD的指导下，建立并维护数据和安全性监查委员会（DSMB）及其活动和审议的所有必要文件，以确保入组各项试验的患者的安全性和福利，并确保所有试验均按照最高科学和伦理标准进行。