Clinical Trials

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❘❙❚■ Chapter 7 | RandomizationTable 4. Treatment assignments based on three prognostic factors for 100 patients.Factor Level Treatment A Treatment B Subtotal TotalAtopy Positive 22 21 43Negative 28 29 57 100FEV 1(%) 40–60 19 18 3761–80 20 21 4181–100 11 11 22 100Age (years)
Clinical Trials: A Practical Guide ■❚❙❘Although this method is mathematically uncomplicated, it has not been widelyused because of the practical difficulties associated with implementing it (somepatient characteristics must be collected and processed before randomization canbe performed, hence slowing down the entire process). However, with increasinguse of computers and, more recently, interactive voice-response systems, thismethod is gaining popularity, particularly in large trials, thereby removing theneed for prespecified randomization lists; and to minimize influence due toimbalances in patients and baseline characteristics of patients.ConclusionSeveral commonly used methods of randomization have been described here, butthere are others. Whichever method is used, the purpose of randomizationremains the same: to validate the assumption that the differences seen in theoutcomes are likely due to differences in the treatments and not the baselinecharacteristics of the patients.References1. Pocock SJ. Clinical Trials: A Practical Approach. New York: John Wiley & Sons, 1983.2. Chow SC, Liu JP. Design and Analysis of Clinical Trials: Concepts and Methodologies.New York: John Wiley & Sons, 1998.73
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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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❘❙❚■ Chapter 2 | Uncontroll
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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 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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