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. Author manuscript; available in PMC: 2019 Aug 23.
Published in final edited form as: Biometrics. 2019 Apr 3;75(2):371–381. doi: 10.1111/biom.12994

Table 1.

Possible relationships between x^ETopt, xETopt, x^Sopt, and xSopt, including comments related to the phase I-II → phase III and phase I-II/III designs. x^ETopt=?xETopt refers to whether or not the optimal dose is selected at the end of phase I-II based on ϕ, and xETopt=?xSopt refers to whether the optimal dose based on μS is the same as that based on ϕ

x^ETopt=?xETopt
xETopt=?xSopt
Comments
x^ETopt=xETopt
xETopt=xSopt
The optimal dose in terms of μS was selected in phase I-II, so it is not desirable to switch doses at stage 2. In this scenario, the phase I-II/III design cannot provide an improvement over phase I-II III.
x^ETopt=xETopt
xEToptxSopt
The dose selected in phase I-II is optimal in terms of ϕ but is not optimal in terms of μS. This illustrates the advantage of the phase I-II/III design over phase I-II III design.
x^EToptxETopt
xETopt=xSopt
The dose selected in phase I-II is suboptimal based on ϕ, but the optimal doses in terms of ϕ and μS are identical. This scenario illustrates the advantage of the phase I-II/III design over phase I-II III design.
x^EToptxETopt
xEToptxSopt
The dose selected in phase I-II is suboptimal based on ϕ, but the optimal doses in terms of ϕ and μS are not identical. This scenario illustrates the advantage of the phase I-II/III design over phase I-II III design.