Clinical Epidemiology
We have conducted numerous projects in clinical settings, focusing on emergent and priority public health concerns. In these studies, eligible study subjects diagnosed with a disease or condition under treatment or observation are monitored for associated outcomes. We have designed and conducted cross-sectional and longitudinal studies in collaboration with domestic and international medical institutions, government health agencies, and private physicians since 1975.
Focus Areas
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Cardiovascular disease
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Cancer
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Hemophilia
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HCV and liver diseases
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HIV/AIDS and other viral infections
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Health disparities
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Risk factor assessment
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Pregnancy outcomes
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Pediatrics and neonatology
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Quality of life
Capabilities
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Study design and development of research questions and hypotheses
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Recruitment of collaborating institutions and study subjects
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Development of protocols, data collection instruments and manuals of operation
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Design of data management systems and project websites
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Training of field staff
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Medical record abstraction
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Web-based data collection and transfer in a secure environment
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Data collection, monitoring, quality control, and adverse event reporting
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Monitoring safety and efficacy and interfacing with DSMBs for randomized clinical trials
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Simultaneous implementation of multiple data collection phases and protocols
Projects
- National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Diseases (2006–2010). A multicenter study to establish a repository of data and biological specimens for investigations to examine the cause, treatment, and outcomes related to genetic thoracic aortic aneurysms and related cardiovascular conditions.
- Data Coordinating and Analysis Center for the Stillbirth Collaborative Research Network (2003–2009). A multicenter cohort and nested case-control study to determine the causes of stillbirth using a standardized stillbirth postmortem protocol, to obtain a geographic population-based determination of the incidence of stillbirth, defined as fetal death at 20 weeks gestation or greater, and to elucidate risk factors for stillbirth.
- Global Network for Women’s and Children’s Health Research (2001-2012). A collaborative effort of international, multidisciplinary teams of investigators working to prevent disease and premature death of women and children in developing countries and to develop research capacity at local foreign organizations and institutions.
- Data Coordinating Center for the Neonatal Research Network (1998–2013). A series of multi-center observational studies and clinical trials of premature infants that test the efficacy and safety of various treatments to improve morbidity and mortality.
- HHV8 and Kaposi’s Sarcoma in Italy (1998–2007). A series of seroprevalence, case-control and clinical trials of elderly Italians diagnosed with endemic, classic Kaposi’s sarcoma.
- Coordinating Center for Clinical Trial of Hypericum Perforatum in Depressive Disorder (1997–2001). A three-arm, double-blind trial to study the acute efficacy and safety of Hypericum perforatum (St. John’s wort) in the treatment of major depression.
- Multicenter Hemophilia Cohort Studies (1986–2005). A series of international longitudinal studies at 54 sites designed to address emergent issues associated with hemophilia and viral infections, including the transmissions of HIV, HBV and HCV and the development of AIDS, non-Hodgkins lymphoma, other cancers and liver diseases.
- Washington DC and New York Gay Men’s Health Study (1986–1999). A collaborative effort with three physicians to identify potential environmental and/or lifestyle exposures which may be associated with immune system dysfunction and the development of AIDS and various types of cancer.
Related Web Sites
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National Heart Lung and Blood Institute (limited access datasets for epidemiology studies and clinical trials)
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National Institute of Child Health and Development (supported research networks)