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. Author manuscript; available in PMC: 2018 Feb 7.
Published in final edited form as: J Biopharm Stat. 2017 Feb 7;27(3):495–506. doi: 10.1080/10543406.2017.1290650

Table 3.

Operating characteristics of the various approaches for selecting initial design for the oncology trial using two-stage Bayesian CRM. The bolded columns represent the true maximum tolerated doses.

Method Initial design Proportion of recommendation DLT Proportion
Dose level MTD below level 1 1 2 3 4 5
pr(DLT) 0.25 0.35 0.50 0.65 0.80
3+3 Design 0.44 0.36 0.18 0.02 0.00 0.00 9 0.40
General (1,1,2,2,18) 0.06 0.64 0.26 0.04 0.00 0.00 24 0.36
Tailored (2,2,2,2,16) 0.06 0.60 0.29 0.05 0.00 0.00 24 0.35
Fixed design 1 (1,1,1,1,20) 0.06 0.54 0.35 0.05 0.00 0.00 24 0.37
Fixed design 2 (3,3,3,3,12) 0.06 0.54 0.35 0.04 0.00 0.00 24 0.35

pr(DLT) 0.15 0.25 0.40 0.55 0.70
3+3 Design 0.21 0.34 0.33 0.11 0.01 0.00 11 0.30
General (1,1,2,2,18) 0.02 0.27 0.48 0.21 0.02 0.00 24 0.29
Tailored (2,2,2,2,16) 0.02 0.22 0.52 0.22 0.02 0.00 24 0.28
Fixed design 1 (1,1,1,1,20) 0.02 0.18 0.57 0.22 0.01 0.00 24 0.30
Fixed design 3 (3,3,3,3,12) 0.02 0.19 0.56 0.21 0.01 0.00 24 0.27

pr(DLT) 0.10 0.15 0.25 0.40 0.55
3+3 Design 0.10 0.19 0.30 0.30 0.10 0.02 14 0.23
General (1,1,2,2,18) 0.01 0.04 0.27 0.46 0.21 0.02 24 0.25
Tailored (2,2,2,2,16) 0.01 0.03 0.27 0.47 0.20 0.02 24 0.24
Fixed design 1 (1,1,1,1,20) 0.01 0.02 0.25 0.54 0.17 0.01 24 0.25
Fixed design 2 (3,3,3,3,12) 0.01 0.02 0.28 0.52 0.16 0.01 24 0.22

pr(DLT) 0.03 0.07 0.15 0.25 0.40
3+3 Design 0.01 0.06 0.17 0.36 0.29 0.10 18 0.16
General (1,1,2,2,18) 0.00 0.00 0.03 0.27 0.47 0.23 24 0.22
Tailored (2,2,2,2,16) 0.00 0.00 0.03 0.28 0.48 0.21 24 0.20
Fixed design 1 (1,1,1,1,20) 0.00 0.00 0.03 0.34 0.51 0.13 24 0.21
Fixed design 2 (3,3,3,3,12) 0.00 0.00 0.03 0.37 0.47 0.14 24 0.17

pr(DLT) 0.01 0.03 0.07 0.15 0.25
3+3 Design 0.00 0.01 0.05 0.17 0.32 0.46 19 0.11
General (1,1,2,2,18) 0.00 0.00 0.00 0.04 0.27 0.69 24 0.17
Tailored (2,2,2,2,16) 0.00 0.00 0.00 0.04 0.31 0.65 24 0.15
Fixed design 1 (1,1,1,1,20) 0.00 0.00 0.00 0.06 0.39 0.56 24 0.17
Fixed design 2 (3,3,3,3,12) 0.00 0.00 0.00 0.07 0.42 0.51 24 0.12