Critical and persistent gaps in the evidence base for neonatal medicine require innovative and rigorous multicenter studies to address them. The NICHD Neonatal Research Network (NRN) investigates the safety and efficacy of treatment and management strategies for newborn infants. There is a crucial need for an independent Data Coordinating Center (DCC) that can provide high-quality and impartial biostatistical expertise to help the NRN target its resources and optimize its scientific impact by (a) helping the NRN identify research topics of high priority, (b) providing objective statistical expertise for the design and analyses of rigorous and feasible studies (especially masked randomized trials and interim monitoring thereof), (c) developing efficient processes and systems for effective use of limited resources, (d) ensuring standardization of study design, development, data collection, and analyses, and (e) dissemination of study results. RTI has been the DCC for the NRN since 1998 and proposes to continue in this role for the next 5 years. We will maximize NRN scientific productivity by (1) enhancing the scientific rigor of the Network with innovative trial designs and statistical methods that address the unique challenges in neonatal research; (2) optimizing productivity by providing flexible and efficient data and study management, and promoting data sharing, integration and harmonization; (3) protecting participant safety and study integrity through reports to the Data Safety and Monitoring Committee; (4) providing timely data analysis, collaborating with investigators on all NRN studies and publications; (5) leveraging the NRN infrastructure and data for external partnerships that support and amplify Network scientific goals; and (6) providing the logistical, communications, and regulatory support necessary to run an efficient and productive multicenter clinical research network. Dr. Abhik Das, the proposed DCC PI, has extensive experience in neonatal clinical studies, leading the NRN DCC for the past 12 years. He will be assisted by Alternate PIs Drs. Marie Gantz and Carla Bann and staff with significant NRN experience. Informed by our past accomplishments, we will support continued success of the NRN in advancing evidence-based neonatal care. This application has unique strengths to help advance the NRN research agenda: (1) a highly qualified and motivated PI and staff with in-depth knowledge and experience in neonatal research (including existing NRN data and active/planned studies), enabling seamless continuation of NRN research without additional training or resources; (2) proven scientific productivity, documented by the quality and quantity of NRN studies and publications supported by RTI that have changed clinical practice; (3) a state-of-the-art infrastructure of tools, processes, and systems that are flexible and customized to the needs of the NRN; (4) multidisciplinary experts who can collaborate with NRN Investigators to realize research goals; (5) robust data capture and management systems customized for the NRN that ensure data quality; and (6) an administrative structure providing maximum staffing flexibility to respond quickly to changing NRN needs.
NICHD established the Neonatal Research Network to investigate persistent unanswered question regarding the safety and efficacy of treatment and management strategies for newborn infants. A Data Coordinating Center (DCC) provides essential expertise to such a large multicenter research enterprise by ensuring rigorous and consistent standards for study design, development, data collection, and data analyses. The DCC also provides objective statistical expertise for formulating, designing, and analyzing studies (especially, masked randomized trials and monitoring thereof), and coordinates communications, regulatory and logistical support across diverse clinical centers.