Table 5.

Simulation results. α is the probability of a type I error or concluding an inferior version of A is better than C under the null. γ₁ is the generalized power at $A\left(x_S^{\mathit{opt}}\right)$ (probability of selecting the best dose $x_S^{\mathit{opt}}$ and declaring it to be superior to C) under the alternative hypothesis. γ₂ is the generalized power (probability of selecting any truly superior dose of A and declaring it superior to C). $\overline{W}$ is the mean improvement in patient survival under the alternative hypothesis, $\overline{\mathit{Dur}}$ is the mean trial duration, and $\overline{N}$ is the mean sample size.

Scenario	Design	Alternative Hypothesis						Null Hypothesis
		$\overline{W}$	γ1	γ2	$\overline{\mathit{Dur}}$	$\overline{N}$		α	$\overline{\mathit{Dur}}$	$\overline{N}$
1	Phase I-II → phase III	4.04	.29	.29	4.05	431.1	–	.02	4.05	461.5
	Phase I-II/III	10.15	.83	.83	4.73	479.2	–	.03	4.32	492.0
2	Phase I-II → phase III	7.87	.66	.66	4.29	459.2	–	.06	4.18	489.4
	Phase I-II/III	8.97	.75	.75	4.45	470.7	–	.02	4.18	489.9
3	Phase I-II → phase III	1.83	.06	.06	3.10	355.0	–	< .01	3.28	385.7
	Phase I-II/III	11.51	.79	.79	4.56	476.9	–	.04	4.22	485.6
4	Phase I-II → phase III	3.52	.25	.25	4.28	475.8	–	.05	3.48	407.8
	Phase I-II/III	5.86	.42	.42	4.30	472.0	–	.05	3.81	442.0
5	Phase I-II → phase III	5.61	.21	.25	3.98	428.5	–	.01	3.83	440.4
	Phase I-II/III	16.71	.68	.88	4.24	464.4	–	.03	4.37	493.9
6	Phase I-II → phase III	9.46	.34	.52	4.16	447.9	–	.02	4.16	466.5
	Phase I-II/III	12.67	.59	.75	4.53	472.7	–	.04	4.39	494.0