Sample Size and Power

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Basic Sample Size Information• What to think about before talkingto a statistician• What information to take to astatistician– In addition to the background to theproject
Sample Size Formula Information• Variables of interest– type of data e.g. continuous, categorical• Desired power• Desired significance level• Effect/difference of clinical importance• Standard deviations of continuousoutcome variables• One or two-sided tests
Page 1 and 2: Sample Size and PowerLaura Lee John
Page 3 and 4: Take Away Message• Get some input
Page 5 and 6: Superiority vs. EquivalenceSuperior
Page 7 and 8: Vocabulary (2)• Follow-up period-
Page 9 and 10: Power Depends on Sample Size• Pow
Page 11 and 12: Power Changes• 2n = 32, 2 sample
Page 13 and 14: Power should be….?• Phase III:
Page 15: OutlinePower‣Basic Sample Size In
Page 19 and 20: Sample Size & Study Design• Rando
Page 21 and 22: Take Away• Study’s primary outc
Page 23 and 24: Sample Size in Clinical Trials• T
Page 25 and 26: Phase I (Old Way)• Enroll 3 patie
Page 27 and 28: Phase IEnroll 3 people0/3 DLT 1/3 D
Page 33 and 34: Phase I (cont.)• Maximum Tolerate
Page 35 and 36: Phase I Note• *Implicitly targets
Page 37 and 38: Phase II Designs• Screening of ne
Page 39 and 40: Phase II Example:Two-Stage Optimal
Page 41 and 42: Two-Stage Optimal Design• Let α
Page 43 and 44: Blow up: Simon (1989) Table
Page 45 and 46: Phase II Example• If 4-10 of the
Page 47 and 48: Phase II• Newer methods are avail
Page 49 and 50: Phase II: Historical Controls• Ol
Page 51 and 52: Phase III Survival Example• Prima
Page 54 and 55: 341213
Page 57 and 58: Non-Survival Simple Sample Size•
Page 59 and 60: Sleep Aid Example• 1 sample test
Page 61 and 62: Sample Size:Change Effect or Differ
Page 63 and 64: Sample Size: Change Power• Change
Page 65 and 66: Sleep Aid Example: 2 ArmsInvestigat
Page 67 and 68:
Aside: 5 Arm Study• Sample size p
Page 69 and 70:
Sample Size: Change Power• Change
Page 71 and 72:
Conclusion• Changes in the differ
Page 73 and 74:
Example• Calculate power with the
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JAVA Sample Size
Page 77 and 78:
Move the Values Around• Sigma (st
Page 79 and 80:
Keep Clicking “OK” Buttons
Page 81 and 82:
Sample Size:Matched Pair Designs•
Page 83 and 84:
Cohen's Effect Sizes• Large (.8),
Page 85 and 86:
Take Home: N• Difference (effect)
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Unequal #s in Each Group• Ratio o
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Unequal #s in Each Group:Fixed # of
Page 91 and 92:
# of Events is Important• Cohort
Page 93 and 94:
# of Covariates and # of Subjects
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OutlinePowerBasic Sample Size Infor
Page 97 and 98:
DNA Microarrays/Proteomics• Same
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Me, too! No, Please Justify N• "A
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Variance?• No prior information o
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OutlinePowerBasic Sample Size Infor
Page 105 and 106:
No Estimate of the Variance?• Mak
Page 107 and 108:
Top 10 Statistics Questions7. Each
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Top 10 Statistics Questions1. Repea
Page 111 and 112:
Resources: General Books• Hulley
Page 113 and 114:
Sample Size Specific Tables• Cont
Page 115 and 116:
Resources: Articles• Schoenfeld,
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Resources: URLs• Sample size calc
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Sample Size and Power

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