Clinical Trials

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❘❙❚■ Chapter 5 | Patient SelectionReferences1. Pfeffer MA, Swedberg K, Granger CB, et al.; CHARM Investigators and Committees.Effects of candesartan on mortality and morbidity in patients with chronic heart failure:the CHARM-Overall programme. Lancet 2003;362:759–66.2. Chow SC, Liu P. Design and Analysis of <strong>Clinical</strong> <strong>Trials</strong>: Concepts and Methodologies.New York: John Wiley & Sons, 1998:94–103.3. European Union. Proposal for a Regulation of the European Parliament and of the Council onMedicinal Products for Paediatric Use and Amending Regulation (EEC) No 1768/92, Directive2001/83/EC and Regulation (EC) No 726/2004. September 29, 2004. Available from:http://pharmacos.eudra.org/F2/Paediatrics/docs/_2004_09/EN.pdf. Accessed February 23, 2005.4. World Medical Association Declaration of Helsinki. Ethical Principles for Medical ResearchInvolving Human Subjects. Available from: www.wma.net/e/policy/b3.htm. Accessed May 6, 2005.54
■■❚❙❘Chapter 6Source and Controlof BiasRadivoj Arezina and Duolao WangThe aim of a randomized controlled trial is to provide unbiasedevaluation of the efficacy and safety of a medicinal product ora therapeutic procedure. Unfortunately, the treatment effectestimates generated in a study are rarely free of all bias. Thisis due to a number of biases or errors that occur during a studyfrom conception, through conduct, to completion of the trial,and even beyond the end of the trial when communicating trialresults. These contributing factors can be classified into threecategories: bias, confounding, and random error. In this chapter,we provide an overview of the ways in which bias can enter atdifferent stages of a clinical trial and review ways of minimizingbias in clinical research.55
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❘❙❚■ ContributorsStephen L
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Clinical Trials: A Practical Guide
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■■❚❙❘Chapter 1RandomizedC
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■■❚❙❘Part IIIBasics ofSta
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■■❚❙❘Chapter 17Types of D
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■■❚❙❘Chapter 19Comparison
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■■❚❙❘Chapter 20Comparison
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■■❚❙❘Chapter 21Analysis o
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■■❚❙❘Part IVSpecial Trial
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■■❚❙❘Chapter 22Intention-
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■■❚❙❘Chapter 23Subgroup A
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■■❚❙❘Chapter 24Regression
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■■❚❙❘Chapter 25Adjustment
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■■❚❙❘Chapter 26Confoundin
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■■❚❙❘Chapter 27Interactio
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■■❚❙❘Chapter 28RepeatedMe
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■■❚❙❘Chapter 29Multiplici
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■■❚❙❘Chapter 31Interim Mo
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■■❚❙❘Chapter Part V32Repo
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■■❚❙❘Chapter 32Overview o
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■■❚❙❘Chapter 33Trial Prof
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■■❚❙❘Chapter 34Presenting
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■■❚❙❘Chapter 35Use of Tab
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■■❚❙❘Chapter 36Use of Fig
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■■❚❙❘Chapter 37Critical A
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■■❚❙❘Chapter 38Meta-Analy
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■■❚❙❘GlossaryGlossary453
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■■❚❙❘AbbreviationsAbbrevi
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■■❚❙❘IndexIndex467
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Clinical Trials

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