Table 2.
Representation of sex, race, and ethnicity in pivotal clinical trials for new molecular entities approved by the U.S. Food and Drug Administration between 1995 and 2019.
| Approval year | Trials, N | Total population, N | Female, n/N (%)a | Caucasian, n/N (%)b | Black, n/N (%)b | Asian, n/N (%)b | Hispanic/Latino, n/N (%)b |
|---|---|---|---|---|---|---|---|
| 1995 | 2 | 545 | 267/545 (48.99) | 496/545 (91.01) | 26/545 (4.77) | 5/545 (0.92) | 16/545 (2.94) |
| 1996 | 4 | 3958 | 2842/3958 (71.80) | 3730/3958 (94.24) | 49/3958 (1.24) | 5/185 (2.70) | 50/185 (27.03) |
| 1997 | 7 | 2348 | 1004/2348 (42.76) | 2038/2348 (86.80) | 103/2348 (4.39) | 27/2348 (1.15) | NR |
| 2000 | 4 | 2119 | 1266/2119 (59.75) | NR | NR | NR | NR |
| 2001 | 4 | 927 | 399/927 (43.04) | 507/927 (54.69) | 162/927 (17.48) | 31/927 (3.34) | 71/338 (21.01) |
| 2003 | 4 | 1690 | 643/1690 (38.05) | 998/1690 (59.05) | 413/1690 (24.44) | 11/598 (1.84) | 85/598 (14.21) |
| 2005 | 2 | 1116 | 418/1116 (37.46) | 753/1116 (67.47) | 91/1116 (8.15) | 44/1116 (3.94) | 107/573 (18.67) |
| 2007 | 1 | 210 | 107/210 (50.95) | 77/210 (36.67) | 5/210 (2.38) | 89/210 (42.38) | 62/210 (29.52) |
| 2009 | 2 | 1794 | 764/1794 (42.59) | 1381/1794 (76.98) | 254/1794 (14.16) | 98/1794 (5.46) | NR |
| 2011 | 8 | 3124 | 1745/3124 (55.86) | 1828/1917 (95.36) | 35/1242 (2.82) | 30/1242 (2.42) | 2/675 (0.30) |
| 2012 | 5 | 1109 | 295/1109 (26.60) | 1005/1005 (100.00) | 0/1005 (0.00) | 0/1005 (0.00) | 2/104 (1.92) |
| 2013 | 5 | 1251 | 372/1251 (29.74) | 939/1251 (75.06) | 259/1001 (25.87) | 0/322 (0.00) | NR |
| 2014 | 10 | 7449 | 2304/7449 (30.93) | 5811/7449 (78.01) | 495/7449 (6.65) | 915/7449 (12.28) | 1091/5490 (19.87) |
| 2015 | 2 | 725 | 295/725 (40.69) | 678/725 (93.52) | NR | NR | NR |
| 2016 | 2 | 1522 | 847/1522 (55.65) | 923/1522 (60.64) | 424/1522 (27.86) | 79/1522 (5.19) | NR |
| 2017 | 4 | 2387 | 937/2387 (39.25) | 1736/2387 (72.73) | 401/2387 (16.80) | 62/2387 (2.60) | 435/1510 (28.81) |
| 2018 | 4 | 3382 | 1648/3382 (48.73) | 2814/3382 (83.21) | 360/3382 (10.64) | 75/3382 (2.22) | 287/968 (29.65) |
| 2019 | 5 | 2664 | 1439/2664 (54.02) | 2351/2664 (88.25) | 165/2664 (6.19) | 64/2664 (2.40) | 406/2664 (15.24) |
| Overall | 75 | 38,320 | 17,592/38,320 (45.91) | 28,065/34,890 (80.44) | 3242/33,240 (9.75) | 1535/27,696 (5.54) | 2614/13,860 (18.86) |
NR, not reported.
a
Data on sex were available for all trials; therefore, percentages were calculated using the corresponding total population.
b
Percentages were adjusted to reflect the proportion among trials that reported data on the demographic, and trial populations with missing or incomplete demographic data were subtracted from the corresponding total population.