Table 3.
Representation of Ethnic/Racial Minorities in Pivotal Drug Trials
| No. of Trials | Overall Population, N | White, n (%) | Black, n (%) | Asian, n (%) | Hispanic/Latino, n (%) | |
|---|---|---|---|---|---|---|
| Overall | 143 | 296 163 | 218 054 (73.6) | 6325 (2.1) | 22 076 (7.5) | 6333 (2.1) |
| Year of drug approval | ||||||
| 2008 | 8 | 3718 | 1427 (38.4) | 97 (2.6) | 1 (0.0) | 8 (0.2) |
| 2009 | 16 | 27 623 | 23 285 (84.3) | 561 (2.0) | 802 (2.9) | 533 (1.9) |
| 2010 | 6 | 22 091 | 15 742 (71.3) | 420 (1.9) | 2898 (13.1) | NR |
| 2011 | 19 | 37 724 | 31 211 (82.7) | 1565 (4.1) | 3005 (8.0) | 961 (2.5) |
| 2012 | 3 | 23 829 | 15 131 (63.5) | 182 (0.8) | 2548 (10.7) | NR |
| 2013 | 21 | 14 261 | 8585 (60.2) | 622 (4.4) | 1772 (12.4) | 1334 (9.4) |
| 2014 | 18 | 37 205 | 27 900 (75.0) | 251 (0.7) | 2355 (6.3) | 312 (0.8) |
| 2015 | 26 | 98 667 | 70 091 (71.0) | 1007 (1.0) | 4674 (4.7) | 719 (0.7) |
| 2016 | 11 | 11 147 | 8028 (72.0) | 372 (3.3) | 771 (6.9) | 888 (8.0) |
| 2017 | 15 | 19 898 | 16 654 (83.7) | 918 (4.6) | 1519 (7.6) | 1578 (7.9) |
| Location | ||||||
| North America | 16 | 32 273 | 26 156 (81.0) | 824 (2.6) | 317 (1.0) | 975 (3.0) |
| Europe | 8 | 39 306 | 23 444 (59.6) | 2 (0.0) | 3081 (7.8) | 1 (0.0) |
| Multiregional | 93 | 209 427 | 158 462 (75.7) | 3848 (1.8) | 16 850 (8.0) | 4028 (1.9) |
| P value | NA | NA | 0.01 | <0.01 | 0.11 | 0.36 |
| Funding | ||||||
| US pharmaceutical | 52 | 115 830 | 83 084 (71.7) | 1782 (1.5) | 3494 (3.0) | 2001 (1.7) |
| Non–US pharmaceutical | 68 | 165 429 | 103 814 (62.8) | 3571 (2.2) | 9850 (6.0) | 4020 (2.4) |
| Collaboration | 23 | 14 904 | 7770 (52.1) | 402 (2.7) | 3026 (20.3) | 312 (2.1) |
| P value | NA | NA | 0.55 | 0.84 | 0.15 | 0.20 |
| Approval pathway | ||||||
| Expedited pathway | 14 | 114 770 | 60 097 (52.4) | 1377 (1.2) | 7631 (6.6) | 531 (0.5) |
| Standard pathway | 129 | 181 393 | 130 452 (71.9) | 4378 (2.4) | 8739 (4.8) | 5802 (3.2) |
| P value | NA | NA | 0.81 | 0.54 | 0.29 | NA |
NA indicates not applicable; and NR, not reported.