A comparison of a new multinomial stopping rule with stopping rules of fleming and gehan in single arm phase II cancer clinical trials

Table 2 Thresholds by DESR to compare with the rules of Gehan (r _alt = 0.2, r _nul = 0.05, epd _alt = 0.4, epd _nul = 0.6, power = 0.8, alpha = 0.05)

Study Size		Stage 1 Drug Rejection		Stage 2 Drug Acceptance		Power	Alpha Error	EN_nul/PES_nul	EN_alt/PES_alt
n ₁	n ₂	n _1r	n _1p	n _1r+n _2r	n _1p+n _2p
14	1	≤1/14	≥8/14	≥2/17	≤7/17	0.835	0.089	14.1/0.89	14.9/0.14
14	3	≤1/14	≥8/14	≥2/17	≤9/17	0.855	0.101	14.3/0.89	17.0/0.008
14	4	≤1/14	≥8/14	≥3/18	≤9/18	0.797	0.051	14.4/0.89	17.4/0.14
14	5	≤1/14	≥8/14	≥3/19	≤9/19	0.787	0.041	14.6/0.89	18.3/0.14
14	6	≤1/14	≥8/14	≥3/20	≤9/20	0.776	0.034	14.7/0.89	19.2/0.14
14	9	≤1/14	≥8/14	≥3/23	≤11/23	0.814	0.04	15.0/0.89	21.7/0.14
14	10	≤1/14	≥8/14	≥3/24	≤12/24	0.829	0.046	15.1/0.89	23.9/0.008
14	11	≤1/14	≥8/14	≥4/25	≤12/25	0.779	0.035	15.2/0.89	24.9/0.008
14	13	≤1/14	≥8/14	≥4/27	≤14/27	0.817	0.032	15.4/0.89	25.2/0.14
14	15	≤1/14	≥8/14	≥4/29	≤14/29	0.807	0.032	15.7/0.89	26.9/0.14
14	16	≤1/14	≥8/14	≥4/30	≤14/30	0.8	0.027	15.8/0.89	27.8/0.14
14	18	≤1/14	≥8/14	≥4/32	≤16/32	0.829	0.026	16.0/0.89	29.5/0.14
14	20	≤1/14	≥8/14	≥5/34	≤17/34	0.809	0.0174	16.2/0.89	31.2/0.14
14	21	≤1/14	≥8/14	≥5/35	≤17/35	0.804	0.021	16.3/0.89	32.0/0.14
14	22	≤1/14	≥8/14	≥5/36	≤19/36	0.83	0.024	16.4/0.89	32.9/0.14
14	23	≤1/14	≥8/14	≥5/37	≤19/37	0.828	0.02	16.5/0.89	33.8/0.14

EN_nul = expected number of patients accrued if a drug meets the criteria of the null hypothesis
EN_alt = expected number of patients accrued if a drug meets the criteria of the alternate hypothesis
PES_nul = probability of stopping the trial after stage I if a drug meets the criteria of the null hypothesis
PES_alt = probability of stopping the trial after stage I if a drug meets the criteria of the alternate hypothesis

ISSN: 1471-2288