Table 5.
Companies’ adherence to data sharing measures.* Values are percentages unless stated otherwise
| Company (new drug application sponsor) | Before 30 day amendment window | After 30 day amendment window | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of applicable trials in new drug application | Policy provides access to analysis-ready dataset and CSR | Policy explains how data may be requested | Company publicly reports No, and outcome of data requests | Policy specifies data will be shared by deadline† | % of covered trials registered | Data sharing score | Policy provides access to analysis-ready dataset and CSR | Policy explains how data may be requested | Company publicly reports No and outcome of data requests | Policy specifies data will be shared by deadline‡ | % of covered trials registered | Data sharing score | ||
| Valeant | 17 | 0 | 0 | 0 | 0 | 71 | 14 | 0 | 0 | 0 | 0 | 71 | 14 | |
| Allergan | 45 | 100 | 100 | 0 | 0 | 96 | 59 | 100 | 100 | 0 | 0 | 96 | 59 | |
| Amgen‡ | 35 | 100 | 100 | 100 | 0 | 31 | 66 | 100 | 100 | 100 | 0 | 31 | 66 | |
| Pfizer | 0 | 100 | 100 | 100 | 0 | NA | 75 | 100 | 100 | 100 | 0 | NA | 75 | |
| AstraZeneca | 10 | 100 | 100 | 0 | 0 | 90 | 58 | 100 | 100 | 100 | 0 | 90 | 78 | |
| Merck§ | 29 | 100 | 100 | 0 | 0 | 83 | 57 | 100 | 100 | 100 | 0 | 100 | 80 | |
| BMS | 13 | 100 | 100 | 0 | 0 | 100 | 60 | 100 | 100 | 100 | 0 | 100 | 80 | |
| Gilead | 10 | 0 | 0 | 0 | 0 | 100 | 20 | 100 | 100 | 0 | 100 | 100 | 80 | |
| Janssen/J&J | 5 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | |
| Novartis | 6 | 100 | 100 | 100 | 0 | 100 | 80 | 100 | 100 | 100 | 100 | 100 | 100 | |
| Novo Nordisk | 46 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | |
| Roche | 1 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | |
| Median (interquartile range) | 12 (6-32) | 100 (100-100) | 100 (100-100) | 50 (0-100) | 0 (0-25) | 100 (86-100) | 63 (58-85) | 100 (100-100) | 100 (100-100) | 100 (75-100) | 0 (0-100) | 100 (93-100) | 80 (73-100) | |
| % of companies fully adopting measures | 83 | 83 | 50 | 25 | 50 | 25 | 92 | 92 | 75 | 42 | 58 | 33 | ||
CSR=clinical study report.
As measured after 30 day window in which companies could improve their data sharing policies to satisfy the current study’s data sharing measures and using trial completion date (rather than primary completion date) to establish the deadline for providing data access.
Deadline refers to cut-off point set forth in this project’s data sharing measure: six months after marketing approval by the Food and Drug Administration and European Medicines Agency or 18 months after the trial’s completion date, whichever is later.
Amgen certifies all 35 trials were sponsored by Les Laboratories Servier, which developed the drug. Amgen is the new drug application holder for and has rights to commercialize Corlanor in the US, through a collaboration with Servier. Additionally, 21 of the 35 trials were completed before 1 January 2005.
Six trials were removed from the “after 30 day amendment window” denominator because Merck certified that those trials’ data are under the control of another company, Organon.