Sample Size and Power

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Phase II Example• Initially enroll 17 patients.– 0-3 of the 17 have a clinical responsethen stop accrual <strong>and</strong> assume not anactive agent• If ≥ 4/17 respond, then accrual willcontinue to 37 patients
Phase II Example• If 4-10 of the 37 respond this isinsufficient activity to continue• If ≥ 11/37 respond then the agent will beconsidered active• Under this design if the null hypothesiswere true (20% response probability)there is a 55% probability of earlytermination
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 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: Blow up: Simon (1989) Table
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
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)
Page 87 and 88: Unequal #s in Each Group• Ratio o
Page 89 and 90: 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
Page 95 and 96:
OutlinePowerBasic Sample Size Infor
Page 97 and 98:
DNA Microarrays/Proteomics• Same
Page 99 and 100:
Me, too! No, Please Justify N• "A
Page 101 and 102:
Variance?• No prior information o
Page 103 and 104:
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
Page 113 and 114:
Sample Size Specific Tables• Cont
Page 115 and 116:
Resources: Articles• Schoenfeld,
Page 117 and 118:
Resources: URLs• Sample size calc
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Sample Size and Power

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