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Table 3 Comparison of the impact of relaxing different eligibility criteria in patients taking drug D2

From: The “RCT augmentation”: a novel simulation method to add patient heterogeneity into phase III trials

Re-included subpopulations Natural augmentation (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 56 0.004 0.733
1 past suicide attempt 73 0.013 0.734
Private practice 69 0.003 0.737
Alcohol abuse 42 −0.008 0.749
Drug abuse 22 −0.004 0.756
Illness duration between 1 and 3 years + 1 past suicide attempt 121 0.033 0.716
Illness duration between 1 and 3 years + private practice 121 0.009 0.719
Illness duration between 1 and 3 years + alcohol abuse 90 0.011 0.728
RCT population not applicable −0.016 0.777
SOHO “real-world population” not applicable 0.000 0.000
  1. Results for the “RCT population” and SOHO “real-world populations” are displayed as benchmark