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Table 1 Characteristics of Single Stage, Simon Two-Stage, and Optimal Two-Stage Designs *

From: Design of Phase II cancer trials evaluating survival probabilities

Design

ESS (%)

MDA (%)

ETSL (%)

MTSL (%)

Single Stage

72.0 (100)

3.00 (100)

4.00 (100)

4.00 (100)

Simon – no interim accrual

53.2 (74)

3.38 (112)

3.63 (91)

5.38 (134)

Simon – interim accrual

67.4 (94)

3.38 (112)

3.22 (80)

4.38 (109)

Proposed – minimize ETSL

63.5 (88)

3.44 (115)

3.00 (75)

4.44 (111)

Proposed – minimize EDA

62.0 (86)

3.27 (109)

3.08 (77)

4.27 (107)

  1. * ESS is the expected sample size; MDA is the maximum duration of accrual; ETSL and MTSL are the expected and maximum total study length, respectively. Expected values are calculated under the null hypothesis; percentages are calculated relative to the single stage values.