Table 1 Relative sizes of patient populations and outcomes across population types
From: The “RCT augmentation”: a novel simulation method to add patient heterogeneity into phase III trials
Population type | % increase in RCT-eligible patient pool (95% CIc) | Outcome Average ΔCGI-S (95% CId) |
|---|---|---|
Patients initiating drug D1 | ||
“Real-world population” (SOHO cohort) | – | −0.88 (− 0.90, − 0.85) |
“RCT population” (22.6% of SOHO cohort patients) | 0 | − 0.78 (− 0.83, − 0.72) |
Augmented RCT populations: | ||
Patients with illness duration between 1 and 3 yearsa | 17.9% (15.5, 20.5%) | −1.04 (− 1.18, − 0.89) |
Patients with one past suicide attempta | 18.1% (15.7, 20.8%) | − 0.94 (− 1.08, − 0.81) |
Private practice patientsa | 14.7% (12.6, 17.1%) | −1.03 (− 1.15, − 0.90) |
Patients with history of alcohol abusea | 6.3% (5.0, 7.8%) | −0.60 (− 0.79, − 0.42) |
Patients with history of drug abusea | 5.6% (4.4, 7.0%) | −0.78 (− 0.99, − 0.57) |
Patients with illness duration between 1 and 3 years and/or one past suicide attemptb | 37.7% (34.0, 41.9%) | −1.00 (− 1.10, − 0.90) |
Patients with illness duration between 1 and 3 years and/or private practice patientsb | 35.1% (31.4, 39.0%) | −1.05 (− 1.15, − 0.96) |
Patients with illness duration between 1 and 3 years and/or history of alcohol abuseb | 25.0% (22.1, 28.3%) | − 0.93 (− 1.05, − 0.81) |
Patients initiating drug D2 | ||
“Real-world population” (SOHO cohort) | – | −0.71 (− 0.75, − 0.67) |
“RCT population” (25.7% of SOHO cohort patients) | 0 | −0.64 (− 0.72, − 0.57) |
Augmented RCT populations: | ||
Patients with illness duration of 1–3 yearsa | 11.7% (8.9, 15.1%) | −0.77 (− 1.03, − 0.51) |
Patients with one past suicide attempta | 15.8% (12.6, 19.8%) | −0.57 (− 0.71, − 0.42) |
Private practice patientsa | 14.9% (11.7, 18.7%) | −0.74 (− 0.93, − 0.55) |
Patients with history of alcohol abusea | 8.7% (6.4, 11.6%) | −0.63 (− 0.97, − 0.30) |
Patients with history of drug abusea | 4.3% (2.8, 6.5%) | −0.50 (− 0.83, − 0.17) |
Patients with illness duration between 1 and 3 years and/or one past suicide attemptb | 29.4% (24.5, 35.0%) | −0.62 (− 0.76, − 0.49) |
Patients with illness duration between 1 and 3 years and/or private practice patientsb | 29.6% (24.7, 35.2%) | −0.79 (− 0.94, − 0.64) |
Patients with illness duration between 1 and 3 years and/or history of alcohol abuseb | 20.5% (16.7, 25.1%) | −0.73 (− 0.93, − 0.52) |