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.