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Health Services Clinical Trials: Design,Conduct, and Cost Methodology
Institution:1. Health Services Research and Development, Veterans Affairs Medical Center, and the Department of Public Health and Preventive Medicine, Oregon Health Sciences University, Portland, Oregon USA;1. Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Switzerland;2. Clinical Trial Unit, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland;3. Institute of Pharmaceutical Medicine, University of Basel, Basel, Switzerland;4. Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute, University of Basel, Basel, Switzerland;5. School of Public Health, Imperial College London, London, United Kingdom;6. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada;7. Multi Organ Transplant Center, King Fahad Specialist Hospital Dammam, P.O. Box 15215, Dammam 31444, Saudi Arabia;8. School of Medicine, University of Toronto, Toronto, Ontario, Canada;9. Department of Medical Oncology, University of Basel and University Hospital Basel, Switzerland;10. Epidemiology, Biostatistics and Prevention Institute, University of Zürich, Zürich, Switzerland;1. Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Basel, Switzerland;2. Clinical Trial Unit, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland;9. Institute of Pharmaceutical Medicine, University of Basel, Basel, Switzerland;8. Department of Medical Oncology, University of Basel and University Hospital Basel, Basel, Switzerland;10. Epidemiology, Biostatistics and Prevention Institute, University of Zürich, Zürich, Switzerland;11. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada;1. Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland;2. Clinical Trial Unit, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland;3. Department of Internal Medicine and Department of Clinical Research, Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland;4. Departments of General Internal and Emergency Medicine and Department of Endocrinology, Diabetology and Clinical Nutrition, Medical University Clinic, Cantonal Hospital Aarau, Aarau, Switzerland;5. Department of Medical Parasitology and Infection Biology, Swiss Tropical and Public Health Institute, University of Basel, Basel, Switzerland;6. Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute, Basel, Switzerland;7. School of Public Health, Imperial College London, London, United Kingdom;8. Department of Medical Oncology, University of Basel and University Hospital Basel, Basel, Switzerland;9. Institute of Pharmaceutical Medicine, University of Basel, Basel, Switzerland;10. Epidemiology, Biostatistics and Prevention Institute, University of Zürich, Zürich, Switzerland;11. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada
Abstract:Randomized clinical trials and their developing methodology have had substantial impact on the advancement of medical practice. With the emergence of managed care and increased emphasis on the reduction of medical care expenditures, cost evaluation is now becoming a part of clinical trial research. The papers by Henderson et al. and Manheim that follow address the evolution of health services research, its application to multicenter clinical trials in a major U.S. health-care system, and methods of assessing costs in health services clinical trials.
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