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Table 1 Thresholds by DESR to compare with rules of Fleming (n1 = 15, n2 = 15, power = 0.8, alpha = 0.05)

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

Response Early Progression Stage 1 Drug Rejection Stage 2 Drug Acceptance Power Alpha Error ENnul/PESnul ENalt/PESalt
r alt r nul epd alt epd nul n 1r n 1p n 1r+n 2r n 1p+n 2p     
0.2 0.05 0.4 0.6 ≤1/15 ≥8/15 ≥4/30 ≤14/30 0.796 0.025 16.4/0.90 27.7/0.15
0.2 0.05 0.3 0.5 ≤1/15 ≥6/15 ≥4/30 ≤11/30 0.785 0.025 16.2/0.92 27.4/0.17
  1. ENnul = expected number of patients accrued if a drug meets the criteria of the null hypothesis
  2. ENalt = expected number of patients accrued if a drug meets the criteria of the alternate hypothesis
  3. PESnul = probability of stopping the trial after stage I if a drug meets the criteria of the null hypothesis
  4. PESalt = probability of stopping the trial after stage I if a drug meets the criteria of the alternate hypothesis