Table 4.

Operating characteristics for the three redesign scenarios of Bokemeyer and others (2009), averaged over simulated trials, for three blocks with patients per block. Each column is a different trial design: AC, FC (0.3,0.3),..., FC (0.5,0.7) are all enrichment trials. These designs do not restrict entry in the first block. ‘A-C’ uses adaptive cutpoints in the second and third blocks with candidate values . ‘F-C(,)’ uses fixed cutpoints with value in block and in block . ‘Non-A’ is a standard unenriched design. ‘Sensitivity’ and ‘Specificity’ are given for detecting the population which benefits. ‘Effect size’ is the true effect size for the designated population. ‘Bias’ is the amount by which each procedure over-estimates that effect size. ‘root-MSE’ is the root-mean-square error of the effect size estimate for the designated population. All operating characteristics, other than power and accrual time, are averaged only over successful trials

		AC	Non-A	FC(0.3,0.3)	FC(0.5,0.5)	FC(0.7,0.7)	FC(0.5,0.7)
1	Power	0.78	0.21	0.74	0.82	0.82	0.83
	Sensitivity	0.98	1	0.99	0.98	0.97	0.98
	Specificity	0.92	0	0.93	0.95	0.89	0.92
	Accrual time	511	336	461	503	552	525
	Effect size	0.21	0.06	0.21	0.22	0.2	0.21
	Bias	0.03	0.07	0.03	0.02	0.02	0.02
	Root-MSE	0.06	0.08	0.06	0.06	0.06	0.06
2	Power	0.86	0.65	0.8	0.86	0.87	0.88
	Sensitivity	0.97	1	0.98	0.98	0.96	0.97
	Specificity	0.62	0	0.58	0.67	0.64	0.67
	Accrual time	459	336	400	451	512	480
	Effect size	0.19	0.13	0.18	0.19	0.19	0.19
	Bias	0.03	0.03	0.04	0.03	0.02	0.03
	Root-MSE	0.06	0.05	0.06	0.06	0.06	0.05
3	Power	0.49	0.03	0.35	0.5	0.58	0.57
	Sensitivity	1	1	1	1	0.99	1
	Specificity	0.8	0	0.84	0.83	0.74	0.79
	Accrual time	544	336	502	556	564	569
	Effect size	0.16	0.01	0.17	0.17	0.14	0.15
	Bias	0.06	0.13	0.07	0.06	0.07	0.06
	Root-MSE	0.08	0.13	0.08	0.07	0.08	0.08