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 lin...

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... time. Essentials of Clinical Research Part I This 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 i...

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... 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. L...

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... 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 re...

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... 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-center interaction in multi-center clinical trials. Statist Med 20: 193 –213. Salsburg DS. ( 199 2) The U...

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... 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 ... use Short-term use of drug Narrowly-specified or restricted population PE-POSTMARKETING Large population of users Long study period Off-label use; new indications Long- term use Hetero- g...

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... 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: D...

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... 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.or...

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... 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. Stat Med. 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: e...

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... 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,...

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