Table 4 Registration and result reporting or publication of clinical trials supporting US FDA cardiovascular device approvals between 2005 and 2020, stratified by study and device characteristics, post-FDAAA (n = 117)
Number of studies (%) | Registered on CT.gov, n (%) | p value | Report results on CT.gov or published, n (%) | p value | |
|---|---|---|---|---|---|
Post-FDAAA | 117 (100) | 115 (98) | 114 (97) | ||
FDA review pathwaya | 0.73 | 0.62 | |||
Priority | 17 (15) | 17 (100) | 17 (100) | ||
Standard | 100 (86) | 98 (98) | 97 (97) | ||
Life-sustaining designationa | 0.20 | 0.42 | |||
Life-sustaining | 65 (56) | 65 (100) | 64 (98) | ||
Non-life-sustaining | 52 (44) | 50 (96) | 50 (96) | ||
Implantable designationa | 0.67 | 0.55 | |||
Non-implantable | 21 (18) | 21 (100) | 21 (100) | ||
Implantable | 96 (82) | 94 (98) | 93 (97) | ||
Combination producta | 0.63 | 0.50 | |||
No | 93 (80) | 91 (98) | 91 (98) | ||
Yes | 24 (21) | 24 (100) | 23 (96) | ||
Company management | 0.63 | 0.70 | |||
Private | 43 (37) | 42 (98) | 43 (100) | ||
Public | 74 (63) | 73 (99) | 72 (97) | ||
Randomized design | 0.60 | 0.25 | |||
No | 74 (63) | 73 (99) | 71 (96) | ||
Yes | 43 (37) | 42 (98) | 43 (100) | ||
Blinded design | 0.26 | 0.64 | |||
No | 101 (86) | 100 (99) | 98 (97) | ||
Yes | 16 (14) | 15 (94) | 16 (100) | ||