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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.