Table 4.
Findings in published reports of studies of high risk cardiovascular devices compared with FDA premarket approval summaries with corresponding publications. Figures are numbers (percentage) unless stated otherwise
| All studies (n=152) | Pivotal studies* (n=127) | |
|---|---|---|
| Primary labeled secondary in publication | 3 (2) | 3 (2) |
| Primary not labeled in publication | 43 (28) | 36 (28) |
| Primary not found in publication | 15 (10) | 14 (11) |
| No primary in either SSED or publication | 4 (3) | 2 (2) |
| Endpoint definition: | ||
| Identical | 110 (72) | 96 (76) |
| Similar | 9 (6) | 9 (7) |
| Unknown | 33 (22) | 22 (17) |
| Discrepancy in control type | 13 (9) | 13 (10) |
| No of patients analyzed: | ||
| Mean difference (range) | 8.9 (-81-272) | 10.6 (-81-272) |
| Mean % difference (range) | 4.3 (-48-131) | 5.3 (-48-131) |
| Absolute mean difference (range) | 15.9 (0-272) | 17.8 (0-272) |
| Absolute % difference (range) | 8.2 (0-131) | 9 (0-131) |
| Discrepancy in No analyzed | 46 (30) | 43 (34) |
| Endpoint results: | ||
| Content: | ||
| Identical | 69 (45) | 55 (43) |
| Similar | 35 (23) | 33 (26) |
| Different | 17 (11) | 16 (13) |
| Unknown | 31 (20) | 23 (18) |
| Discrepancies in direction of favorability: | ||
| Discrepancy | 6 (4) | 6 (5) |
| No discrepancy | 75 (49) | 61 (48) |
| Unknown if discrepancy | 71 (47) | 60 (47) |
SSED=summary of safety and effectiveness data.
*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