PEDIATRIC TRIALS NETWORK - BPCA

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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.