Table 2.
Representation of Women in Pivotal Drug Trials
| No. of Trials | Overall Population, N | Women, n (%) | P Value | |
|---|---|---|---|---|
| Overall | 143 | 296 163 | 108 052 (36.4) | |
| Year of drug approval | ||||
| 2008 | 8 | 3718 | 1100 (29.6) | 0.29a |
| 2009 | 16 | 27 623 | 10 147 (36.7) | |
| 2010 | 6 | 22 091 | 8429 (38.2) | |
| 2011 | 19 | 37 724 | 15 481 (41.0) | |
| 2012 | 3 | 23 829 | 8751 (36.7) | |
| 2013 | 21 | 14 261 | 7230 (50.7) | |
| 2014 | 18 | 37 205 | 11 419 (30.7) | |
| 2015 | 26 | 98 667 | 31 368 (31.8) | |
| 2016 | 11 | 11 147 | 4451 (39.9) | |
| 2017 | 15 | 19 898 | 9676 (48.6) | |
| Location | ||||
| North America | 16 | 32 273 | 9595 (29.7) | <0.01 |
| Western/Central Europe | 8 | 39 306 | 9765 (24.8) | |
| Multiregional | 93 | 209 427 | 81 643 (39.0) | |
| Funding | ||||
| US pharmaceutical | 52 | 115 830 | 39 695 (34.3) | 0.19 |
| Non–US pharmaceutical | 68 | 165 429 | 61 134 (37.0) | |
| Collaboration | 23 | 14 904 | 7223 (48.5) | |
| Approval pathway | ||||
| Expedited pathway | 14 | 114 770 | 36 293 (31.6) | 0.03 |
| Standard pathway | 129 | 181.393 | 71 759 (39.6) | |
a
Simple linear regression used.