Clinical Trials

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❘❙❚■ Chapter 13 | Bioequivalence <strong>Trials</strong>5. Hauck WW, Anderson S. A new statistical procedure for testing equivalence in two-groupcomparative bioavailability trials. J Pharmacokinet Biopharm 1984;12:83–91.6. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach forassessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 1987;15:657–80.7. Westlake WJ. Statistical aspects of comparative bioavailability trials. Biometrics 1979;35:273–80.130
■■❚❙❘Chapter 14Noninferiority <strong>Trials</strong>Sam Miller, Colin Neate, and Duolao WangA noninferiority trial aims to demonstrate that the effect of anew treatment is as good as, or better than, that of an activecomparator. This is assessed by demonstrating that the newtreatment is not worse than the comparator by more than aspecified margin (the noninferiority margin [δ]). In this chapter,we discuss in detail, using a recent trial, situations wherenoninferiority trials are appropriate, factors to be consideredwhen choosing an appropriate δ, methods for sample sizedetermination, and the issues involved in the analysis andevaluation of noninferiority.131
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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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■■❚❙❘Chapter 3Protocol De
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■■❚❙❘Chapter 4EndpointsAm
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■■❚❙❘Chapter 5Patient Sel
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■■❚❙❘Chapter 6Source and
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■■❚❙❘Chapter 18Significan
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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 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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