Table 1 True and false positive rates of significant subgroup effects in simulated trials under different scenarios
From: Cumulative subgroup analysis to reduce waste in clinical research for individualised medicine
Variables | Input values | True positive | False positive | |||
|---|---|---|---|---|---|---|
X1 | X2 | X3 | X4 | Any of X2, X3, X4 | ||
Ratio of odds ratios (ROR) | 0.90 | 6.2% | 4.9% | 5.0% | 5.0% | 14.2% |
0.80 | 10.3% | 5.0% | 5.1% | 4.9% | 14.2% | |
0.70 | 17.9% | 4.8% | 5.0% | 5.0% | 14.1% | |
No. of patients per arm | 200 | 7.5% | 4.9% | 4.9% | 5.1% | 14.1% |
400 | 10.1% | 5.0% | 5.0% | 4.8% | 14.2% | |
600 | 12.6% | 5.1% | 5.0% | 4.8% | 14.2% | |
Event rate in the control arm | 0.20 | 8.7% | 4.9% | 5.1% | 5.0% | 14.3% |
0.30 | 10.2% | 5.2% | 5.1% | 5.1% | 14.6% | |
0.40 | 11.3% | 5.1% | 4.9% | 5.1% | 14.4% | |
Proportion of patients belonging to a subgroup | 20% | 8.0% | 4.6% | 5.0% | 4.9% | 14.2% |
30% | 9.3% | 5.1% | 4.9% | 4.9% | 14.4% | |
40% | 10.0% | 5.3% | 4.9% | 5.1% | 14.5% | |