Branch Activities: Cooperative Agreements

To respond to the need for well-designed clinical trials in maternal-fetal medicine and neonatology, the NICHD established two large-scale Networks—the NRN and the MFMU Network—as administrative frameworks in which to conduct multicenter, randomized clinical trials and other prospective clinical studies in obstetrics and neonatology. Each Network is guided by a Steering Committee, which consists of representatives from each clinical site, from the PPB, and from the data-coordinating center. These Networks allow for a timely response to urgent clinical questions in a cost-effective manner. Currently, the NRN has 16 sites, and the MFMU Network has 14 sites. Sites are selected every five years following an open competition. Typically each Network has two to three randomized controlled trials and two to three observational studies ongoing at any given time. Network investigators agree to use common protocols, definitions, and data forms and are linked by their common data centers and common data-entry computer systems. Investigators, together with the PPB and the data-center staff, develop protocols that are reviewed by Advisory Boards, external reviewers, and Data Safety and Monitoring Committees (DSMCs). The DSMCs, which are established for each Network, ensure that the trials are safe and scientifically significant.

There are several advantages to doing clinical trials within the Networks. First, the Networks provide large populations with which to conduct studies, with adequate statistical power to resolve many research questions; inadequate sample size is a common limitation of many published clinical trials. Approximately 120,000 births occur per year in the MFMU Network, and 100,000 infants are born per year in the NRN. Second, because the study population is diverse, a therapy or management strategy shown to be effective across an array of ethnic and socioeconomic backgrounds and health care settings is more likely to prove effective in real-world clinical practice. Third, the data-coordinating centers attached to the Networks have sufficient resources to assure excellent study management and data quality. Finally, the administrative systems of the Network are efficient and cost-effective. To ensure their cost-effectiveness, the Networks are funded through a combination of a minimum base budget and capitated funds for enrollment in specific protocols. New trials can be brought online relatively rapidly because the infrastructure is already in place. The Networks address the need for clinical trials in neonatology and obstetrics, especially those relating to the prevention of LBW infants (<1,500 grams) and their management. The Networks build upon contributions to the clinical trial field and are unique in that they rely, to a greater extent, on shared responsibility and commitment. The following section describes the PPB-supported Networks and other efforts funded through cooperative agreements.

   Neonatal Research Network (NRN)
   Maternal Lifestyles Study (MLS)
   Maternal-Fetal Medicine Units (MFMU) Network
   The Collaborative Home Infant Monitoring and Evaluation (CHIME) Study
   New PPB-Supported Networks

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