Table 2 Comparison of the impact of relaxing different eligibility criteria in patients taking drug D1
From: The “RCT augmentation”: a novel simulation method to add patient heterogeneity into phase III trials
Re-included subpopulations | Natural augmentation (number of patients re-included when opening the trial to the specific “real-world population” subgroup) | Prediction bias with natural augmentation | Mean squared error (MSE) of prediction with natural augmentation | |
|---|---|---|---|---|
Relaxed eligibility criteria | Illness duration between 1 and 3 years | 188 | 0.033 | 0.818 |
1 past suicide attempt | 190 | 0.057 | 0.820 | |
Private practice | 159 | 0.041 | 0.830 | |
Alcohol abuse | 73 | 0.054 | 0.836 | |
Drug abuse | 65 | 0.053 | 0.833 | |
Illness duration between 1 and 3 years + 1 past suicide attempt | 339 | 0.024 | 0.803 | |
Illness duration between 1 and 3 years + private practice | 321 | 0.024 | 0.814 | |
Illness duration between 1 and 3 years + alcohol abuse | 248 | 0.037 | 0.812 | |
RCT population | not applicable | 0.054 | 0.852 | |
SOHO “real-world population” | not applicable | 0.000 | 0.000 | |