Enrichment Bayesian design for randomized clinical trials using categorical biomarkers and a binary outcome

Table 1 Description of the simulated scenarios when K = 2

Scenarios	Subset B		Subset A		Theoretical Values
Outcomes	p_1B	p_0B	p_1A	p_0A	θ_A	θ_B/θ_A	RR
Scenario 1	0.40	0.40	0.30	0.30	1.000	1.000	1.000
Scenario 2	0.40	0.40	0.30	0.40	0.750	1.330	0.875
Scenario 3	0.40	0.40	0.20	0.37	0.540	1.850	0.779
Scenario 4	0.40	0.40	0.20	0.50	0.400	2.500	0.647

Here, p_jk denotes the probability of death in the arm j in the subset k, and θ_k denotes the relative risk of death in the experimental versus the control arm in subset k. RR refers to the overall treatment effect.

ISSN: 1471-2288