Sample Size and Power

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Phase I: Dose Escalation• Dose limiting toxicity (DLT) mustbe defined• Decide a few dose levels (e.g. 4)• At least three patients will betreated on each dose level (cohort)• Not a power or sample sizecalculation issue
Phase I (Old Way)• Enroll 3 patients• If 0 out of 3 patients develop DLT– Escalate to new dose• If DLT is observed in 1 of 3 patients– Exp<strong>and</strong> cohort to 6– Escalate if 0 out of the 3 new patientsdo not develop DLT (i.e. 1/6 at thatdose develop DLT)
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 and 16: OutlinePower‣Basic Sample Size In
Page 17 and 18: Sample Size Formula Information•
Page 19 and 20: Sample Size & Study Design• Rando
Page 21 and 22: Take Away• Study’s primary outc
Page 23: Sample Size in Clinical Trials• T
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
Page 75 and 76:
JAVA Sample Size
Page 77 and 78:
Move the Values Around• Sigma (st
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Keep Clicking “OK” Buttons
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Sample Size:Matched Pair Designs•
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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
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# 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
Page 101 and 102:
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
Page 109 and 110:
Top 10 Statistics Questions1. Repea
Page 111 and 112:
Resources: General Books• Hulley
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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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