Table 2 Registration, result reporting, and publication of clinical trials supporting US FDA cardiovascular device approvals between 2005 and 2020, pre- and post-FDAAA (n = 165)
Number of studies (%) | Registered on CT.gov, n (%)a | Risk ratio (95% CI) | Report results on CT.gov, n (%) | Risk ratio (95% CI) | Published, n (%)a | Risk ratio (95% CI) | |
|---|---|---|---|---|---|---|---|
Overall | 165 (100) | 139 (84) | 105 (76) | 128 (78) | |||
Trial completion date | 1.97 (1.48 to 2.61) | 5.74 (2.88 to 11.44) | 1.47 (1.14 to 1.88) | ||||
Pre-FDAAA | 48 (29) | 24 (50) | 7 (15) | 28 (58) | |||
Post-FDAAA | 117 (71) | 115 (98) | 98 (84) | 100 (85) | |||
p value | < 0.001 | < 0.001 | < 0.001 |