Data Coordinating Center Projects
National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (1998-2013)
RTI provides statistical and data coordinating services to the NICHD Neonatal Research Network (https://neonatal.rti.org/), a cooperative group of 16 U.S. hospitals. These hospitals enroll premature babies into clinical trials and observational studies that test the efficacy and safety of various treatments, with several protocols active at any given time. The network has been functioning for more than 20 years, with RTI as the data coordinating center (DCC) since 1998. As the DCC, RTI provides the following support: study design; development and distribution of study materials; development of randomization systems; development and implementation of data entry and management systems; production of enrollment, quality assurance, safety, and efficacy reports; and data analysis and manuscript preparation. Active studies in the network include ongoing registries for low birth-weight infants, clinical trials, observational studies, and a longitudinal study on long-term developmental outcomes.
RTI serves as the data coordinating and analysis center for this international network initially funded by the Gates Foundation and the NICHD. The research commitment of the Global Network emphasizes the development, testing, and adaptation of cost-effective, integrated biomedical, behavioral, social, and public health interventions to reduce morbidity and mortality among reproductive age women and young children in developing countries. Each of 10 research units conducted its own protocol(s) during the first phase of the study. The study focus is shifting to collaborative research protocols related to common problems affecting women's and children's health across the six research units funded for the second phase of the study. Collaborative efforts have included a protocol with the National Cancer Institute to assess tobacco use among pregnant women and a cluster-randomized neonatal resuscitation protocol. Sustainability and quality assurance of the data are major components of this study and are especially challenging given the diversity of the participating international communities.
Randomized Controlled Trial of Male Circumcision to Reduce HIV Incidence in Kisumu, Kenya (2002-2010)
This collaborative study is funded jointly by the National Institute of Allergy and Infectious Disease and the Canadian Institutes of Health Research through the University of Illinois at Chicago. The study is an unblinded randomized trial with treatment (circumcised) and control (uncircumcised) cohorts. RTI's responsibilities include data management, statistical expertise in collaboration with other investigators, data analysis and reporting, and user support of the data entry and management systems located at the clinical site in Kenya. The trial was stopped in December 2006 after the Data and Safety Monitoring Board reviewed an interim analysis prepared by RTI and deemed male circumcision to be efficacious. Follow-up of trial participants continues.
Sponsored by the National Institute of Mental Health, this trial examines the efficacy of a community-level intervention to reduce HIV/STD incidence and high-risk behaviors in international populations threatened by the disease. The study is testing a sophisticated intervention model using both behavioral and biological outcomes in a large-scale, multisite, Phase III randomized controlled study. In each of the five country sites -- China, India, Peru, Russia, and Zimbabwe -- Community Popular Opinion Leaders (C-POLs) are engaged as behavior change agents within the community. Among other activities, RTI is developing and implementing data collection/management systems and procedures, overseeing and assisting with ethnographic studies, developing systems for tracking and managing biological specimens, and providing statistical leadership and quality assurance.
National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Other Cardiovascular Conditions (2006-2010)
RTI serves as the data coordinating center for this National Heart, Lung, and Blood-sponsored registry, which includes five clinical centers. Clinical, laboratory, and family pedigree data, as well as biological specimens, are being collected and analyzed on approximately 3,500 patients who are receiving treatment for aortic aneurysms, aortic dilatation, aortic insufficiency, heart failure, or aortic valve repair in which a genetic component is suspected. The information collected by the registry will facilitate research to determine the best medical practices that will advance the clinical management of genetic thoracic aortic aneurysms and other cardiovascular complications. RTI staff will design all of the data collection materials and train the nurse coordinators in the collection and shipping of biospecimens and the completion of all clinical forms. The forms will be keyed through the secure project Web site by clinical center staff. The Web-based data management system will provide dynamic reports on the status of patient enrollment and follow-up evaluations, entry of data forms, and diagnosis of significant events. RTI will also be responsible for all data analysis and dissemination of findings through preparation of manuscripts and presentations at scientific meetings in collaboration with the investigators from the clinical centers.