Sample Size and Power

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Phase I Enroll 3 people 0/3 DLT 1/3 DLT 2 or 3 / 3 DLT Escalate to new dose Enroll 3 more at same dose 0/new 3 DLT 1 or more / new 3DLT Escalate to new dose Stop Stop Drop down dose; start over
Number of pts with DLT Decision 0/3 Escalate one level 1/3 Enroll 3 more at current level 0/3 + 0/3 STOP and choose current level as MTD (To get here a de-escalation rule must have been applied at the next higher dose level) 1/3 + 0/3 Escalate one level (unless a de-escalation rule was applied at next higher level, in which case choose current level as MTD) 1/3 + {1/3* or 2/3 or 3/3} STOP* and choose previous level as MTD (unless previous level has only 3 patients, in which case treat 3 more at previous level) 2/3 or 3/3 STOP and choose previous level as MTD (unless previous level has only 3 patients, in which case treat 3 more at previous level)
Page 1 and 2: Sample Size and Power Laura Lee Joh
Page 3 and 4: Misconceptions • A small p-value
Page 5 and 6: Take Away Message • Get some inpu
Page 7 and 8: Superiority vs. Equivalence Superio
Page 9 and 10: Vocabulary (2) • Follow-up period
Page 11 and 12: Power Depends on Sample Size • Po
Page 13 and 14: Power Changes • 2n = 32, 2 sample
Page 15 and 16: Power should be….? • Phase III:
Page 17 and 18: Outline Power ‣Basic Sample Size
Page 19 and 20: Basic Sample Size Information • W
Page 21 and 22: Take Away • Study’s primary out
Page 23 and 24: Sample Size Formula Information •
Page 25 and 26: Sample Size & Study Design • Rand
Page 27 and 28: Phase I: Dose Escalation • Dose l
Page 29 and 30: Phase I (cont.) • Maximum Tolerat
Page 31 and 32: Phase I Enroll 3 people 0/3 DLT 1/3
Page 33 and 34: Phase I Enroll 3 people 0/3 DLT 1/3
Page 35: Phase I Enroll 3 people 0/3 DLT 1/3
Page 39 and 40: Phase I • MANY new methods • Se
Page 41 and 42: Phase II Design Problems • Might
Page 43 and 44: Phase II Example: Two-Stage Optimal
Page 45 and 46: Table from Simon (1989)
Page 47 and 48: Phase II Example • Initially enro
Page 49 and 50: Sample Size Differences • If the
Page 51 and 52: Phase II: Historical Controls • W
Page 53 and 54: Study Design Phase II Summary Advan
Page 55: Number of Patients to Enroll? • 1
Page 58: Phase III Survival • Look at nomo
Page 61 and 62: 1-Sample N Example • Study effect
Page 63 and 64: Short Helpful Hints • In humans n
Page 65 and 66: Sample Size: Iteration and the Use
Page 67 and 68: Sample Size: Change Standard d Devi
Page 69 and 70: Sleep Aid Example: 2 Arms Investiga
Page 71 and 72: Sample Size: Change Effect or Diffe
Page 73 and 74: Sample Size: Change Standard d Devi
Page 75 and 76: Live Statistical Consult! • Sampl
Page 77 and 78: Sample Size Rulers
Page 79 and 80: Put in 1-Sample Example #s • 1 ar
Page 81 and 82: Put in 2-Sample Example #s • 2 ar
Page 83 and 84: Other Designs?
Page 85 and 86: Examples in the Text • Several wi
Page 87 and 88:
Take Home: What you need for N •
Page 89 and 90:
Outline Power Basic sample size inf
Page 91 and 92:
K:1 Sample Size Shortcut • Use eq
Page 93 and 94:
How many controls? k = 2n n 0 − n
Page 95 and 96:
Formulas and Example Risk of event
Page 97 and 98:
Balanced Designs: Easier to Find Po
Page 99 and 100:
Multiple Comparisons • If you hav
Page 101 and 102:
Outline Power Basic Sample Size Inf
Page 103 and 104:
No Prior Information • "Sample si
Page 105 and 106:
Number of Available Patients • "T
Page 107 and 108:
Conclusions: What Impacts Sample Si
Page 109 and 110:
Top 10 Statistics Questions 10.Exac
Page 111 and 112:
Top 10 Statistics Questions 4. Inte
Page 113 and 114:
Analysis Follows Design Questions
Page 115 and 116:
Resources: General/Text Books • A
Page 117 and 118:
Resources: Articles • Simon R. Op
Page 119 and 120:
Resources: FDA Guidance • http://
Page 121:
Questions?
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Sample Size and Power

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