Essentials of Clinical Research - part 9 doc
Essentials of Clinical Research - part 9 doc
... they made the rank of full professor by age 40. The, resulting data is portrayed in Table 18.1. From a review of Table 18.1 what types of estimates of the measure of asso-ciation can we make ... nature of data. The rate of change of one variable tied to the rate of change of another is known as a slope. The correlation coefficient and the slope of the regression line are functions of one ... The standard deviation of means is called the standard error of the mean. The real trick of the field of statistics is to provide an estimate of the stand-ard error of a parameter when the...
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Essentials of Clinical Research - part 1 doc
... time. Essentials of Clinical Research Part IThis Part addresses traditional clinical research, beginning with the history of the development of clinical research, to traditional clinical research ... selected mile-stones in the history of clinical research include:● Fisher’s introduction of the concept of randomization in 192 6.5● The announcement in 193 1 by the Medical Research Council ... flip of a coin determined which group received the study drug.7Further analysis of the tuberculosis streptomycin study of 194 8 is regarded as the beginning of the modern era of clinical research...
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Essentials of Clinical Research - part 2 doc
... 199 5;273(18):142 1-1 428. 19. Lang JM. The use of a run-in to enhance compliance. Stat Med. Jan-Feb 199 0 ;9( 1-2 ):8 7 -9 3; discussion 9 3-8 5.20. Shem S. The House of God: Palgrace Macmillan; 197 8:280.21. Smith ... the pre-specified study endpoint was 1 month?3 Clinical Trials 61 8. Grimes DA, Schulz KF. An overview of clinical research: the lay of the land. Lancet. Jan 5 2002;3 59( 9300):5 7-6 1. 9. Loscalzo ... 199 4;330(15):102 9- 1 035.24. Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published ran-domised controlled trials. Bmj. Sep 11 199 9;3 19( 7211):67 0-6 74.25. Influence of adherence...
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Essentials of Clinical Research - part 5 docx
... monitoring of clinical tri-als. Lancet. Dec 4, 199 9; 354 (91 94): 198 3– 198 8.11. Peto R, Pike MC, Armitage P, et al. Design and analysis of randomized clinical trials requiring prolonged observation of ... Pharmacological Basis of Therapeutics. 9th ed. New York: McGraw-Hill; 199 6. 19. Makuch RW, Johnson MF. Dilemmas in the use of active control groups in clinical research. IRB. Jan–Feb 198 9; 11(1):1–5.20. ... patients partici-pate in clinical research? Associates of Clinical Pharmacology 199 3 Annual Meeting; 199 3.14. Mapstone J, Elbourne DR, Roberts I. Strategies to improve recruitment in research...
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A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 9 doc
... Chuang-Stein C, Offen W. (2005) Analysis of Clinical Trials Using SAS: A Practical Guide. SAS Publishing.Donegani M. ( 199 1) An adaptive and powerful test. Biometrika 78 :93 0 93 3.Entsuah AR. ( 199 0) ... 6:77–81.Pothoff RF; Peterson BL; George SL. (2001) Detecting treatment-by-centerinteraction in multi-center clinical trials. Statist Med 20: 193 –213.Salsburg DS. ( 199 2) The Use of Restricted ... rank-sum, andlog-rank tests. JASA 83:52–61.Oosterhoff J. ( 196 9) Combination of One-Sided Statistical Tests.Mathematisch Centrum Amsterdam.Peddiwell JA; Benjamin HH ( 195 9) Saber-Tooth Curriculum....
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Essentials of Clinical Research - part 3 ppt
... C, Peck C. Postmarketing drug dosage changes of 499 FDA-approved new molecular entities, 198 0– 199 9. Pharmacoepidemiol Drug Saf. Sept 2002; 11(6):4 39 446.32. FDA news Drug Daily Bulletin. Oct ... useShort-termuse of drugNarrowly-specifiedor restrictedpopulationPE-POSTMARKETINGLargepopulation of usersLong studyperiodOff-label use;new indicationsLong-term useHetero-geneouspopulationExposure ... Tognoni G, Alli C, Avanzini F, et al. Randomised clinical trials in general practice: lessons from a failure. BMJ. Oct 19, 199 1; 303(6808) :96 9 97 1.22. Ben-Menachem E. Data from regulatory studies:...
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Essentials of Clinical Research - part 4 potx
... in the 199 7 law. According to this law, the Food and Drug Administration Modernization Act of 199 7 reauthorizes the Prescription Drug User Fee Act of 199 2, regulating advertis-ing of unapproved ... promotion. JAMA. Nov 14, 199 0; 264(18):24 09 2415.40. 21 CFR Part 310 section 502(a) of the Food and Drug Administration Modernization Act of 199 7 (Modernization Act) In: Department of Health and Human ... used in the mid- 197 0s. By 199 6, more than 650,000 of these procedures were performed in US.27A definitive randomized trial of the efficacy of this procedure was not begun until 199 5. That trial...
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Essentials of Clinical Research - part 6 ppsx
... Mar 1, 199 2; 69( 6):681–686. 3. Oxman AD. Meta-statistics: help or hindrance? ACP J Club. 199 3. 4. Goodman SN. Have you ever meta-analysis you didn’t like? Ann Intern Med. Feb 1, 199 1; 114(3):244–246. ... L, Kumar S. Application of evidence-based urology in improving quality of care. Indian J Urol 2007; 23(2) :91 96 .22. The Problem of Induction ( 195 3, 197 4). http://dieoff.org/page126.htm23. ... studies in meta-analyses.18. Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst. Apr 195 9; 22(4):7 19 748. 19. Berlin JA,...
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Essentials of Clinical Research - part 7 ppt
... case-crossover study. Pharmacoepidemiol Drug Saf. Feb 2007; 16(2):1 89 196 .58. Greenland S. A unified approach to the analysis of case-distribution (case-only) studies. StatMed. Jan 15 199 9; ... 1, 199 9; 1 49( 11) :98 1 98 3.62. Stukel TA, Fisher ES, Wennberg DE, Alter DA, Gottlieb DJ, Vermeulen MJ. Analysis of observational studies in the presence of treatment selection bias: effects of ... 199 5; 48(6): 191 2– 191 9. 19. Morlans M, Laporte JR, Vidal X, Cabeza D, Stolley PD. End-stage renal disease and non-narcotic analgesics: a case-control study. Br J Clin Pharmacol. Nov 199 0; 30(5):717–723.20....
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Essentials of Clinical Research - part 8 ppsx
... measure of effectiveness, the distinction above is important, especially in cases of medium to high event rates or probabili-ties. If action A carries a risk of 99 .9% and action B a risk of 99 .0% ... Journal of Epidemiology, 197 0– 199 0. Am J Epidemiol. May 15, 199 4; 1 39( 10):1047–1052.10. Sterne JA. Teaching hypothesis tests–time for significant change? Stat Med. Apr 15, 2002; 21(7) :98 5 99 4; ... and NPVCAC Se % Sp % PPV % NPV %Age 40 to 49 1 88 61 17 98 100 47 94 42 95 300 18 97 60 93 Age 60 to 69 1 100 26 41 100300 74 81 67 86700 49 91 74 78CAC=Calcium artery Scores; Se=Senvitivity,...
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