Table 3 Median values [95% range] in 10,000 simulated trials of median progression-free survival (PFS), hazard ratio, number of events and analysis time (in months), and power for the fictitious trial of Scenario 2 (N = 220 patients; target = 162 events), without pandemic (base case) and with 6-month shutdown periods occurring at various times
Shut-down period | Parameter | Treatment policy strategy | Hypothetical strategy | Hypothetical strategy, delayed analysis | Interval censoring |
|---|---|---|---|---|---|
6 to 12 months | Median PFS, control | 13.0 [10.5–16.0] | 18.0 [16.0–22.0] | 18.0 [16.0–22.0] | Low: 11.0 [4.0–14.0] High: 13.0 [10.5–16.0] |
Median PFS, experimental | 21.0 [16.0–27.0] | 26.0 [22.0–34.0] 67 median estimates not reached | 26.0 [22.0–34.0] | Low: 19.0 [14.0–25.0] High: 21.0 [16.0–27.0] | |
Hazard ratio | 0.60 [0.44–0.82] | 0.60 [0.41–0.86] | 0.60 [0.43–0.81] | 0.60 [0.44–0.82] | |
Power | 89.8% | 78.3% | 90.2% | 89.2% | |
Number of events | 162 [162–162] | 113 [101–124] | 162 [162–162] | 162 [162–162] | |
Analysis time | 34.6 [29.8–39.9] | 80.8 [58.0–176.9] | 34.6 [29.8–39.9] | ||
12 to 18 months | Median PFS, control | 14.9 [13.2–17.1] | 18.0 [16.0–22.0] | 18.0 [16.0–22.0] | Low: 8.0 [6.0–14.0] High: 14.9 [13.2–17.1] |
Median PFS, experimental | 21.0 [16.5–27.0] | 26.0 [22.0–34.0] 76 median estimates not reached | 26.0 [22.0–34.0] | Low: 19.0 [10.0–25.0] High: 21.0 [16.5–27.0] | |
Hazard ratio | 0.60 [0.44–0.82] | 0.60 [0.42–0.85] | 0.60 [0.43–0.82] | 0.60 [0.44–0.82] | |
Power | 89.7% | 81.4% | 90.5% | 89.2% | |
Number of events | 162 [162–162] | 125 [114–135] | 162 [162–162] | 162 [162–162] | |
Analysis time | 34.6 [29.8–39.9] | 58.8 [47.1–79.1] | 34.6 [29.8–39.9] | ||
18 to 24 months | Median PFS, control | 13.0 [10.0–19.6] | 13.0 [10.0–22.0] | 13.0 [10.0–22.0] | Low: 11.0 [8.0–12.0] High: 13.0 [10.0-19.6] |
Median PFS, experimental | 22.0 [19.3–27.0] | 26.0 [22.0–34.0] 68 median estimates not reached | 26.0 [22.0–34.0] | Low: 15.0 [12.0–25.0] High: 22.0 [19.3–27.0] | |
Hazard ratio | 0.60 [0.44–0.82] | 0.60 [0.42–0.84] | 0.60 [0.42–0.84] | 0.60 [0.44–0.82] | |
Power | 89.8% | 84.0% | 90.0% | 89.2% | |
Number of events | 162 [162–162] | 134 [124–143] | 162 [162–162] | 162 [162–162] | |
Analysis time | 34.6 [29.8–39.9] | 50.0 [ 41.5–62.7] | 34.6 [29.8–39.9] | ||
24 to 30 months | Median PFS, control | 13.0 [10.0–16.0] | 13.0 [10.0–16.0] | 13.0 [10.0–16.0] | Low: 11.0 [8.0–14.0] High: 13.0 [10.0–16.0] |
Median PFS, experimental | 24.3 [16.0–28.0] | 26.0 [16.0–32.0] 92 median estimates not reached | 26.0 [16.0–34.0] | Low: 18.0 [14.0–21.0] High: 24.4 [16.0–28.0] | |
Hazard ratio | 0.60 [0.44–0.83] | 0.60 [0.43–0.84] | 0.60 [0.44–0.82] | 0.60 [0.44–0.82] | |
Power | 89.2% | 85.6% | 90.1% | 89.1% | |
Number of events | 162 [162–162] | 141 [132–149] | 162 [162–162] | 162 [162–162] | |
Analysis time | 34.6 [30.0–39.9] | 45.3 [37 − 9–54.8 ] | 34.6 [29.8–39.9] | ||