Table 3. Evaluation bias between central versus local assessments.
Summary/subgroup | ORR (Exp/Con) | DCR (Exp/Con) | |||||||
---|---|---|---|---|---|---|---|---|---|
S (n) | OR (95% CI) | P† | I2‡§ (%) | S (n) | OR (95% CI) | Pa | I2‡§ (%) | ||
Summary | 28 | 1.02 (0.97–1.07) | 0.42 | 0 | 16 | 0.98 (0.93–1.03) | 0.37 | 0 | |
Mask | |||||||||
Open | 22 | 1.03 (0.98–1.09) | 0.23 | 30 | 12 | 0.97 (0.91–1.02) | 0.25 | 0 | |
Blind | 6 | 0.95 (0.84–1.08) | 0.43 | 4 | 1.01 (0.91–1.13) | 0.79 | |||
Sample size | |||||||||
> median (618.5) | 14 | 1.00 (0.94–1.06) | 0.99 | 1 | 10 | 0.96 (0.91–1.02) | 0.21 | 0 | |
< median (618.5) | 14 | 1.05 (0.97–1.14) | 0.20 | 6 | 1.03 (0.92–1.15) | 0.63 | |||
Tumor type | |||||||||
NSCLC | 8 | 1.01 (0.93–1.10) | 0.81 | 0 | 4 | 1.01 (0.91–1.12) | 0.85 | 0 | |
Breast | 7 | 1.08 (0.98–1.20) | 0.13 | 5 | 0.98 (0.89–1.07) | 0.62 | |||
Renal-cell | 6 | 1.01 (0.91–1.12) | 0.86 | 4 | 0.95 (0.87–1.05) | 0.35 | |||
Ovarian | 3 | 0.98 (0.85–1.12) | 0.72 | 1 | 0.91 (0.77–1.09) | 0.32 | |||
Others | 4 | 1.00 (0.86–1.15) | 0.99 | 2 | 1.04 (0.83–1.30) | 0.73 | |||
Primary endpoint | |||||||||
Central-assessed | 16 | 1.04 (0.98–1.10) | 0.22 | 50 | 10 | 0.97 (0.91–1.04) | 0.37 | 0 | |
Others | 7 | 0.92 (0.83–1.03) | 0.16 | 5 | 0.99 (0.90–1.08) | 0.76 | |||
Local-assessed | 5 | 1.08 (0.94–1.24) | 0.28 | 1 | 0.99 (0.80–1.23) | 0.93 | |||
Primary outcome | |||||||||
Positive | 18 | 1.04 (0.98–1.11) | 0.23 | 0 | 10 | 0.99 (0.93–1.06) | 0.76 | 0 | |
Indeterminate | 1 | 1.10 (0.61–1.95) | 0.76 | 1 | 0.98 (0.68–1.42) | 0.92 | |||
Negative | 9 | 0.99 (0.92–1.07) | 0.84 | 5 | 0.96 (0.88–1.04) | 0.30 |
†, P value for the comparison between central and local assessments; P<0.05 indicated significant discrepancy; ‡, I2 in summary outcome was for heterogeneity of data synthesis; §, I2 in subgroup was for subgroup difference, representing the interaction effects between the elements of each subgroup factor. Exp, experimental arm; Con, control arm; ORR, objective response rate; DCR, disease control rate; OR, odds ratio; S, study.