10class.wk1 - PubH 7420 Clinical Trials: Readings for Week...

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PubH 7420 Clinical Trials: Readings for Week 1 1. Fundamentals of Clinical Trials , Chapter 1 Supplemental Reading/References 1. Epidemiology series, Lancet (a series of articles published in 2002). 2. Hill AB: Observation and experiment. NEJM , 248: 995-1001, 1953. 3. Jaffe H et al. Acquired immune deficiency syndrome in the United States: The first 1,000 cases. J Inf Dis 148:330-345, 1983 - case series . 4. Moertel CG et al. A clinical trial of amygdalin (Laetrile) in the treatment of human cancer. NEJM , 306, 201-206, 1982 – uncontrolled trial of an intervention . 5. Hennekens C et al. Coffee drinking and death due to coronary heart disease. NEJM , 294, 633-636, 1976 - case-control study. 6. Shekelle R et al. The MRFIT Behavior Pattern Study II. Type A behavior and incidence of coronary heart disease. Amer J Epid , 122, 559-570, 1985 - prospective follow - up study . 7. Aspirin Myocardial Infarction Study Research Group. A randomized controlled trial of aspirin in persons recovered from myocardial infarction. JAMA , 243, 661-669, 1980 - clinical trial . 8. Cornfield J: Statistical relationships and proof in medicine. Amer Stat , 8(5): 19-21, 1954. 9. Davey Smith G et al. Confounding in epidemiologic studies: why "independent" effects may not be all they seem. BMJ 305:757-759, 1992. 10. Davey Smith G et al. Smoking as "independent" risk factor for suicide: Illustration of an artifact from observational epidemiology? Lancet 340:709-712, 1992. 11. MacMahon S, Collins R. Reliable assessment of the effects of treatment on mortality and major morbidity, II. Observational studies. Lancet 2001;357:455-462. 12. Cochran WG. Research techniques in the study of human beings. Milbank Memorial Fund Quarterly , 2:121-136, 1955. 13. Spilker B. Guide to Clinical Trials , Raven Press, New York, 1991. 14. Clinical Trials; A Practical Approach . Chapters 1, 2, and 4. 15. Clinical Trials. Design, Conduct and Analysis , Part I, Chapters 1-7. 1
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Methods of Investigation in Clinical Research A. Chance observations - uncontrolled leads - the basis for many, if not most, important discoveries. e.g. discovery of digitalis - Withering in 1775 noted that this drug which was derived from the Foxglove plant was associated with respiratory and cardiac symptoms when prescribed for dropsy cases. He proceeded to record observations on a series of cases. e.g. discovery of penicillin - Fleming observed an unusual contamination from the air of some plates lying in his laboratory. e.g. aspirin for the prevention of heart attacks - in the 1940s, a graduate of the University of Minnesota (L.L. Craven) observed bleeding among children who chewed aspirin gum after tonsillectomies. This led him to hyothesize that aspirin might be better than anticoagulants for heart attack patients. B.
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This note was uploaded on 11/21/2011 for the course PUBH 7420 taught by Professor Ph7420 during the Spring '07 term at Minnesota.

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10class.wk1 - PubH 7420 Clinical Trials: Readings for Week...

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