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. RTI has been the DCC for the NRN since 1998 and proposes to continue in this role for the next 5 years, providing data management and analysis, statistical expertise, and logistical services. We will maximize NRN productivity by (1) collaborating to develop, implement, and monitor rigorous multicenter studies; (2) providing flexible and efficient data and study management; (3) producing data/safety reports for the Data and Safety Monitoring Committee (DSMC). NRN investigators, and public use data files; (4) collaborating in analyses and publications for NRN studies; and (5) providing the logistical, communications, and regulatory support (including clinical centers' capitation funding) necessary for an efficient and productive research network. Dr. Abhik Das, the proposed DCC PI, has extensive experience in neonatal clinical trials, leading the NRN DCC for 9 years. He will be assisted by Alternate Pis Drs. Dennis Wallace and Marie Gantz and other experienced biostatisticians with significant NRN experience. While proud of our past accomplishments, our goal is to continually adapt and seek opportunities to evolve as research needs and technologies evolve. As needed. RTI will continue to (1) develop innovative trial designs to address the unique challenges in neonatal trials; (2) refine assessment of safety/efficacy for proximal/distal outcomes; (3) conduct early phase drug trials; and (4) leverage trial data with sound secondary studies to answer important questions (e.g., genomics and economic analyses).This application has unique strengths to help advance the NRN research agenda: (1) staff and infrastructure with years of NRN experience and in-depth knowledge of active and planned NRN studies, enabling seamless continuation of NRN research without additional training or resources; (2) proven track record of scientific productivity, as documented in the quality and quantity of NRN trials and studies, presentations, and publications supported by RTI; (3) multidisciplinary experts in biostatistics, clinical trials, psychometry, bioinformatics, and health economics, who can collaborate with NRN Investigators to realize research goals; (4) robust data management system customized for the NRN, incorporating automated intra/cross-form edits, comprehensive reporting, and randomization systems; and (5) flexible staffing structure that optimizes personnel resources to respond quickly to changing NRN needs.
NICHD established the NRN to investigate persistent unanswered question regarding the safety and efficacy of treatment and management strategies for newborn infants. A DCC provides essential expertise to such a large multicenter research enterprise and ensure standardization of study design, development, data collection, and data analyses; provides objective statistical expertise in formulating, designing, and analyzing studies (especially, blinded randomized trials and monitoring thereof); and coordinates communications and logistical support across diverse clinical centers.
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