Table 3.
Comparison of study characteristics reported in FDA premarket approval summaries with corresponding publications and those published studies. Figures are numbers (percentage) unless stated otherwise
| All (n=86) | Pivotal (n=66)* | ||||||
|---|---|---|---|---|---|---|---|
| Summary | Published | Odds ratio (95% CI), P value† | Summary | Published | Odds ratio (95% CI), P value† | ||
| Randomized | 34 (40) | 34 (40) | 1.00 (0.43 to 2.33), 1.0 | 28 (42) | 28 (42) | 1.00 (0.38 to 2.62), 1.0 | |
| Blinded studies | 23 (27) | 23 (27) | 1.00 (0.37 to 2.67), 1.0 | 16 (24) | 16 (24) | 1.00 (0.33 to 3.06), 1.0 | |
| Double blind | 13 (15) | 13 (15) | 1.00 (0.35 to 2.85), 1.0 | 10 (15) | 10 (15) | 1.00 (0.32 to 3.11), 1.0 | |
| Single blind | 10 (12) | 10 (12) | 1.00 (0.32 to 3.16), 1.0 | 6 (9) | 6 (9) | 1.00 (0.25 to 3.95), 1.0 | |
| Multicenter | 73 (85) | 76 (89) | 1.45 (0.54 to 3.89), 0.46 | 64 (97) | 65 (99) | —‡ | |
| Single center | 8 (9) | 7 (8) | —‡ | 1 (2) | 1 (2) | —‡ | |
| No of centers not specified | 5 (6) | 3 (4) | 0.58 (0.13 to 2.53), 0.47 | 1 (2) | 0 (0) | —‡ | |
| Exclusively US sites | 37 (43) | 43 (50) | 1.42 (0.73 to 2.77), 0.31 | 35 (53) | 36 (55) | 1.09 (0.49 to 2.42), 0.84 | |
| Location not specified | 24 (28) | 14 (16) | 0.49 (0.23 to 1.04), 0.07 | 12 (18) | 10 (15) | 0.80 (0.31 to 2.03), 0.64 | |
*Study was classified as pivotal if it was only one included in summary, multicenter randomized controlled trial, or explicitly noted in summary as being pivotal study.
†As calculated by generalized linear mixed effects model with canonical logit link and random effect placed on the intercept to account for heterogeneity across devices.
‡Too few events or counter-events for fitting of random effects model.