Table 4.
Companies’ adherence to transparency measures relating to trial registration, results reporting, and publication. Values are number with event/No in sample (percentage) unless stated otherwise
| Drug | Company | Trials in patients | All trials | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Registered | Reported | Published | Publicly available | Registered | Reported | Published | Publicly available | |||
| Avycaz | Cerexa/Allergan | 9/9 (100) | 0/8 (0) | 2/8 (25) | 2/8 (25) | 19/26 (73) | 3/25 (12) | 13/25 (52) | 14/25 (56) | |
| Viberzi | Forest/Allergan | 3/3 (100) | 0/3 (0) | 1/3 (33) | 1/3 (33) | 3/14 (21) | 0/14 (0) | 2/14 (14) | 2/14 (14) | |
| Vraylar | Forest/Allergan | 21/23 (91) | 0/22 (0) | 9/22 (41) | 9/22 (41) | 22/38 (58) | 0/36 (0) | 9/36 (25) | 9/36 (25) | |
| Corlanor | Amgen | 12/36 (33) | 9/35 (26) | 13/35 (37) | 16/35 (46) | 12/72 (17) | 9 /71 (13) | 21/71 (30) | 24/71 (34) | |
| Kybella | Kythera/Allergan | 15/16 (94) | 8/13 (62) | 2/13 (15) | 8/13 (62) | 23/26 (88) | 8/22 (36) | 4/22 (18) | 10/22 (45) | |
| Addyi | Sprout/Valeant | 12/17 (71) | 11/17 (65) | 7/17 (41) | 13/17 (76) | 14/54 (26) | 12/54 (22) | 7/54 (13) | 14/54 (26) | |
| Yondelis | Janssen/Johnson & Johnson | 10/16 (63) | 6/13 (46) | 11/13 (85) | 11/13 (85) | 12/28 (43) | 8/24 (33) | 15/24 (63) | 15/24 (63) | |
| Zurampic | Ardea/AstraZeneca | 10/11 (91) | 6/9 (67) | 1/9 (11) | 7/9 (78) | 18/41 (44) | 6/39 (15) | 5/39 (13) | 11/39 (28) | |
| Genvoya | Gilead | 18/20 (90) | 15/18 (83) | 14/18 (78) | 17/18 (94) | 18/33 (55) | 15/31 (48) | 14/31 (45) | 17/31 (55) | |
| Farydak | Novartis | 21/22 (95) | 18/21 (86) | 18/21 (86) | 20/21 (95) | 21/22 (95) | 18/21 (86) | 18/21 (86) | 20/21 (95) | |
| Daklinza | BMS | 26/26 (100) | 14/24 (58) | 20/24 (83) | 23/24 (96) | 30/54 (56) | 17/52 (33) | 29/52 (56) | 32/52 (62) | |
| Ibrance | Pfizer | 7/7 (100) | 5/5 (100) | 4/5 (80) | 5/5 (100) | 24/24 (100) | 5/20 (25) | 4/20 (20) | 5/20 (25) | |
| Alecensa | Roche | 5/5 (100) | 1/2 (50) | 2/2 (100) | 2/2 (100) | 10/10 (100) | 1/7 (14) | 3/7 (43) | 3/7 (43) | |
| Cotellic | Genentech/ Roche | 3/3 (100) | 0/1 (0) | 1/1 (100) | 1/1 (100) | 9/10 (90) | 1/8 (13) | 4/8 (50) | 4/8 (50) | |
| Entresto | Novartis | 24/24 (100) | 22/22 (100) | 10/22 (45) | 22/22 (100) | 25/47 (53) | 23/45 (51) | 14/45 (31) | 27/45 (60) | |
| Odomzo | Novartis | 15/15 (100) | 10/11 (91) | 3/11 (27) | 11/11 (100) | 15/19 (79) | 10/15 (67) | 4/15 (27) | 12/15 (80) | |
| Bridion | Merck | 30/36 (83) | 36/36 (100) | 32/36 (89) | 36/36 (100) | 33/54 (61) | 39/54 (72) | 45/54 (83) | 52/54 (96) | |
| Tagrisso | AstraZeneca | 12/12 (100) | 5/5 (100) | 1/5 (20) | 5/5 (100) | 15 /15 (100) | 8/8 (100) | 2/8 (25) | 8/8 (100) | |
| Tresiba/ Ryzodeg | Novo Nordisk | 83/83 (100) | 78/78 (100) | 53/78 (68) | 78/78 (100) | 87/87 (100) | 82/82 (100) | 53/82 (65) | 82/82 (100) | |
| Total (median) No of trials analyzed | 384 (16) | 343 (13) | 343 (13) | 343 (13) | 674 (28) | 628 (25) | 628 (25) | 628 (25) | ||
| Median (interquartile range) (%) | 100 (91-100) | 65 (36-96) | 45 (30-84) | 95 (69-100) | 61 (49-93) | 33 (14-59) | 31 (23-54) | 55 (31-72) | ||
In 2017, Addyi was reacquired by Sprout Pharmaceuticals. In 2016, Odomzo was acquired by Sun Pharmaceuticals. Amgen is the US new drug application holder and has rights to commercialize Corlanor in the US, through a collaboration with Les Laboratoires Servier. Corlanor is the subject of a licensing agreement between Amgen Servier, executed in June 2013. All studies included in the Corlanor US new drug application were sponsored by Les Laboratoires Servier. Additionally, 21 trials submitted in the new drug application were completed before 2005. Three trials supporting approval of Yondelis were conducted by PharmaMar, and another two studies were investigator initiated. All five of these studies were publicly available. One trial in Alecensa was conducted by Chugai Pharmaceuticals. This trial was publicly available. Two trials in Avycaz were sponsored by AstraZeneca; Pfizer is now responsible to submit results. Each of these trials is publicly available. Allergan acquired Avycaz, Kybella, Viberzi, and Vraylar before approval by the Food and Drug Administration and notes that results submission is in process for trials without results on ClinicalTrials.gov for each of these drugs.