PEDIATRIC TRIALS NETWORK - BPCA

儿科试验网络 - BPCA

• 批准号: 10619427
• 负责人: RAVINDER ANAND
• 金额: $ 60万
• 依托单位: THE EMMES COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-07-29 至 2022-05-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10619427
• 关键词: Affect; Award; Biological Products; COVID-19; Centers for Disease Control and Prevention (U.S.); Child; Child Development; Childhood; Clinical; Clinical Data; Clinical Research; Clinical Trials; Clinical Trials Network; Communities; Contractor; Contracts; Data; Data Coordinating Center; Data Files; Data Set; Devices; Documentation; Drug usage; Environment; Fast Healthcare Interoperability Resources; Funding; Individual; Infrastructure; Institutes; Knowledge; Label; Leadership; Longterm Follow-up; Malignant Childhood Neoplasm; Metadata; Modeling; Modification; Monitor; Multisystem Inflammatory Syndrome in Children; National Heart, Lung, and Blood Institute; National Institute of Child Health and Human Development; Obstetric pharmacology; Patients; Pediatric Research; Pharmaceutical Preparations; Pilot Projects; Preparation; Procedures; Process; Protocols documentation; Research; Research Personnel; Resources; Risk; Services; Site; Staging; Structural Congenital Anomalies; Structure; Syndrome; System; Therapeutic; TimeLine; United States National Institutes of Health; Work; base; catalyst; clinical research site; cloud based; cohort; computerized data processing; data analysis pipeline; data de-identification; data infrastructure; data management; data resource; data sharing; data submission; development policy; experience; improved; indexing; information gathering; interoperability; operation; pediatric patients; pediatric pharmacology; phenotypic data; pre-clinical; preclinical trial; prevent; programs; prospective; repository; sharing platform; statistics; structured data; therapy development; web site

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 (see BPCA website for more information at (www.bpca.nichd.nih.gov ). 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 the various clinical activities in the BPCA program. This infrastructure requires a high level of interaction with the NICHD and the other responsible parties. 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, hence forth termed Contractors, within the Consortium that support BPCA initiatives and projects: The BPCA Data Coordinating Center (DCC) (this procurement) manages and houses all of the data generated by the Pediatric Trials Network and the previous data from the legacy studies under the BPCA 2002. All completed trials are then submitted to the NICHD DASH Repository. The DCC also provides leadership in statistics and in the preparation and tracking of all FDA regulatory documents generated under prospective BPCA clinical trials.  The BPCA Pediatric Trials Network (PTN) (awarded in 2010) serves as the master Contractor for the conduct of pre-clinical and clinical trial studies under the BPCA.

NICHD，特别是产科和儿科药理学和治疗学分支（OTTPB），管理研究计划（因此称为“BPCA计划”），并与其他NIH研究所和中心（IC）合作开展重要的儿科研究，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列表，并赞助了这些优先治疗药物的临床试验（更多信息请参见BPCA网站（www.bpca.nichd.nih.gov））。自2002年BPCA成立以来，NICHD已经授予了大约35个项目，目的是收集信息，以改善儿童使用药物的标签。 NICHD目前维持着一个合同基础设施，为BPCA计划中的各种临床活动提供支持。这一基础设施需要与国家排雷中心和其他负责方进行高度互动。这一结构，此后称为“联盟”，共同努力，建设，实施，监测和审计临床前和临床活动，以改善知识和标签的药物，生物制品和设备用于儿童。以下是支持BPCA倡议和项目的联合体内的责任方，因此称为承包商： BPCA数据协调中心（DCC）（本次采购） 管理和保存儿科试验网络生成的所有数据以及BPCA 2002遗留研究的先前数据。所有已完成的试验都将提交给NICHD DASH Repository。DCC还在统计以及编制和跟踪前瞻性BPCA临床试验生成的所有FDA监管文件方面发挥领导作用。  BPCA儿科试验网络（PTN） （于2010年批出）为BPCA下进行临床前及临床试验研究的总承判商。