Table 3.
Representation of sex, race, and ethnicity in pivotal clinical trials by location, sponsor type, and approval pathway.
| 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 |
|
|---|---|---|---|---|---|---|---|
| Location | |||||||
| North America | 35 | 16,545 | 8224/16,545 (49.71%) |
10,557/13,304 (79.35%) |
1429/13,304 (10.74%) |
297/11,132 (2.67%) | 954/5014 (19.03%) |
| Europe | 1 | 278 | 128/278 (46.04%) |
268/278 (96.40%) |
1/278 (0.36%) |
9/278 (3.24%) |
NR |
| Multicontinental | 39 | 21,497 | 9240/21,497 (42.98%) |
17,240/21,308 (80.91%) |
1812/19,658 (9.22%) |
1229/16,286 (7.55%) |
1660/8846 (18.77%) |
| p-value | 0.339 | 0.228 | 0.339 | 0.511 | 0.577 | ||
| Sponsor Type | |||||||
| US pharmaceutical | 42 | 22,335 | 9081/22,335 (40.66%) |
14,242/18,905 (75.33%) |
2186/18,905 (11.56%) |
1221/17,134 (7.13%) |
1841/8798 (20.93%) |
| Non-US pharmaceutical | 31 | 13,983 | 7365/13,983 (52.67%) |
12,271/13,983 (87.76%) |
755/12,333 (6.12%) |
250/8560 (2.92%) |
486/4094 (11.87%) |
| Collaboration | 2 | 2002 | 1146/2002 (57.24%) |
1552/2002 (77.52%) |
301/2002 (15.03%) |
64/2002 (3.20%) |
287/968 (29.65%) |
| p-value | 0.042 | 0.002 | 0.002 | 0.102 | 0.021 | ||
| Approval Pathway | |||||||
| Standard | 50 | 25,451 | 12,337/25,451 (48.47%) |
19,106/23,676 (80.70%) |
2385/23,196 (10.28%) |
820/18,744 (4.37%) |
1486/8109 (18.33%) |
| Priority | 25 | 12,869 | 5255/12,869 (40.83%) |
8959/11,214 (79.89%) |
857/10,044 (8.53%) |
715/8952 (7.99%) |
1128/5751 (19.61%) |
| p-value | 0.753 | 0.398 | 0.336 | 0.696 | 0.300 | ||
NR, not reported.
p-value indicates the significance of the difference between the distributions of the demographic proportions of the categories.
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.