Clinical Trials

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❘❙❚■ Chapter 20 | Comparison of ProportionsIn the case of the MI trial data, the calculated Z = –3.55, which corresponds toa probability of P < 0.001. The estimated difference in proportions is –2.78%with a 95% CI of (–4.32%, –1.24%). Since the absolute Z-value is >Z 0.05/2= 1.96with an associated P-value of
<strong>Clinical</strong> <strong>Trials</strong>: A Practical Guide ■❚❙❘use log (RR) and its standard error to derive a Z-statistic and test the nullhypothesis using the following formula:log RRZ =SE(log RR)SE(log RR) = √1/a – 1/n 1+ 1/b – 1/n 2where SE(log RR) is the standard error of log RR [3].In the MI trial example:SE(log RR) = √1/110 – 1/2045 + 1/165 – 1/2022 = 0.12Z =log RR= log(0.66) = –3.46SE(log RR) 0.12This corresponds to a P-value of
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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 7Randomizati
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❘❙❚■ Chapter 8 | BlindingBl
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❘❙❚■ Chapter 8 | BlindingTh
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❘❙❚■ Chapter 8 | BlindingAs
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❘❙❚■ Chapter 9 | Sample Siz
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■■❚❙❘Part IIAlternativeTr
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❘❙❚■ Chapter 10 | Crossover
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❘❙❚■ Chapter 11 | Factorial
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❘❙❚■ Chapter 12 | Equivalen
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❘❙❚■ Chapter 13 | Bioequiva
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❘❙❚■ Chapter 14 | Noninferi
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❘❙❚■ Chapter 15 | Cluster R
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❘❙❚■ Chapter 16 | Multicent
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■■❚❙❘Part IIIBasics ofSta
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■■❚❙❘Chapter 17Types of D
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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 30Missing Da
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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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