Welcome to. The Fundamentals of International Clinical Research Workshop. Stevenson, Washington
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1 Welcome to The Fundamentals of International Stevenson, Washington Robin M. Mason, MS, MBA Division of Microbiology and Infectious Diseases of Allergy and Infectious Diseases NIH, DHHS
2 Fundamentals of International Welcome to scientists from:
3 s of Health >18,000 employees Office of the E. A. Zerhouni, M.D. $28 B USD budget 83% budget to research grants >325,000 investigators >3,000 Institutions National Cancer Institute National Eye Institute National Heart Lung and Blood Institute on Aging Clinical Center Center for Information Technology Center for Scientific Review John E. Fogarty Center for Advanced Study in the Health Sciences on Alcohol Abuse and Alcoholism of Allergy and Infectious Diseases of Arthritis and Musculoskeletal and Skin Diseases of Child Health and Human Development National Center for Complementary and Alternative Medicine National Center for Minority Health and Health Disparities National Center for Research Resources National Human Genome Research Institute on Drug Abuse of Deafness and Other Communication Disorders of Dental and Craniofacial Research of Diabetes and Digestive and Kidney Diseases of Biomedical Imaging and Bioengineering of Environmental Health Sciences of General Medical Sciences of Nursing Research of Mental Health of Neurological Disorders and Stroke National Library of Medicine
4 of Allergy and Infectious Diseases NIAID A. S. Fauci, M.D. 1,617 NIAID employees $4.412 B USD 2006 Office of Global Affairs Administrative Offices Office of Division of Intramural Research Vaccine Research Center Division of Extramural Activities Division of Microbiology and Infectious Diseases Division of Allergy, Immunology, and Transplantation Division of AIDS Grants Management Program
5 Division of Microbiology and Infectious Diseases Dr. Carole Heilman Dr. Irene Glowinski Deputy Microbial Genomics and Advanced Technologies Dr. Maria Giovanni Assistant Clinical Research Coordination Deborah Katz Acting Associate International Research in Infectious Diseases Dr. Polly Sager Assistant Office of Biodefense Research Affairs Dr. Michael Kurilla Office of Regulatory Affairs Dr. Robert Johnson Office of Clinical Research Affairs Dr. Shy Shorer Office of Scientific Coordination and Program Operations Dr. Barbara Mulach Bacteriology and Mycology Branch Dr. Dennis Dixon Enteric and Hepatic Diseases Branch Dr. Leslye Johnson Sexually Transmitted Infections Branch Dr. Carolyn Deal Respiratory Diseases Branch Dr. Linda Lambert Parasitology and International Programs Branch Dr. Lee Hall Virology Branch Dr. Catherine Laughlin
6 Fundamentals of International NIAID of Allergy and Infectious Diseases, part of National Institutes of Health (NIH) Large international research portfolio Over $135 M for international research (nonaids) About 250 projects in 60 countries About ¾ projects are in less developed countries (LDC)
7 DMID International Research International Collaborations in Infectious Disease Research (ICIDR) Bangladesh, Brazil, Chile, Colombia, Egypt, Gabon, Gambia, Ghana, Kenya, Malawi, Mali, Panama, Papua New Guinea, Philippines, Tanzania, Thailand Tropical Medicine Research Centers Tuberculosis Research Units Brazil, Uganda Sexually Transmitted Infections Clinical Units Madagascar, Uganda Bacteriology and Mycology Study Group Thailand Group A Strep Fiji, Mali, Nicaragua, South Africa
8 Fundamentals of International Key challenges facing global health efforts The threat of emerging and re-emerging diseases the ever-present threat of pandemic influenza Avian influenza HIV/AIDS pandemic West Nile virus in the United States, Malaria and TB The spread of drug resistance seen in all classes of microbial pathogens The development of collaborative infrastructures and technologies to aid research and training at an international level The threat of bioterrorism
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10 Fundamentals of International Resources to assist with clinical research: NIAID/DMID staff Site monitoring, regulatory assistance, protocol templates (DMID) FHI International Clinical Sciences Support Center Site assessment/readiness Protocol preparation Study design and methodology Data management Statistical analysis Case report form development
11 Fundamentals of International Objective: strengthen our understanding of clinical research Principles Guidelines Implementation Focus on protocol development as framework Conducted by NIAID/NIH and Family Health International
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