PEDIATRIC TRIALS NETWORK - BPCA

NICHD，特别是产科和儿科药理学和治疗学分会(OTTPB)负责管理研究计划(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，以完成改善儿科治疗的任务。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(有关更多信息，请参阅BPCA网站(www.bpca.nichd.nih.gov)。自2002年BPCA成立以来，NICHD授予了大约35个单独的项目，目的是收集信息，改善儿童使用的药物的标签。 NICHD目前维护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排雷中心和其他责任方进行高水平的互动。这一结构此后被称为“联盟”，它共同努力构建、实施、监测和审计临床前和临床活动，以改善儿童使用的药物、生物制品和设备的知识和标签。以下是财团内支持BPCA倡议和项目的责任方，因此称为承包商： BPCA数据协调中心(DCC)(本次采购) 管理和存储儿科试验网络产生的所有数据和根据BPCA 2002进行的遗留研究的先前数据。所有完成的试验然后提交给NICHD DASH储存库。DCC还在统计以及准备和跟踪根据预期的BPCA临床试验产生的所有FDA监管文件方面发挥领导作用。 BPCA儿科试验网络(PTN) (于2010年授予)担任英国防止虐待动物协会下进行临床前和临床试验研究的总承包商。

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.