Table 1.
Demographics of Clinical Trial Participants of New Drugs Approved by FDA CDER (2013–2015)
| 2013 | 2014 | 2015 | Entire study period | |
|---|---|---|---|---|
| New drugs approved, na | 24 | 40 | 38 | 102 |
| Total sex reported | 108,132 | 152,609 | 224,135 | 484,876 (>99.9%)b |
| Men | 57,743 (53.4%) | 95,012 (62.3%) | 136,379 (60.8%) | 289,134 (59.6%) |
| Women | 50,389 (46.6%) | 57,597 (37.7%) | 87,756 (39.2%) | 195,742 (40.4%) |
| Total race reported | 104,269 | 152,266 | 216,308 | 472,843 (97.5%)b |
| White | 80,120 (76.8%) | 117,761 (77.3%) | 166,986 (77.2%) | 364,867 (77.2%) |
| Black/AA | 6,824 (6.5%) | 9,896 (6.5%) | 13,590 (6.3%) | 30,310 (6.4%) |
| Asian | 11,837 (11.4%) | 17,493 (11.5%) | 28,424 (13.1%) | 57,754 (12.2%) |
| AI/AN | 1,127 (1.1%) | 1,053 (0.7%) | 841 (0.4%) | 3,021 (0.6%) |
| NH/OPI | 120 (0.1%) | 217 (0.1%) | 338 (0.2%) | 675 (0.1%) |
| Hispanic/Latino | 155 (0.1%) | 1,597 (1.0%) | 892 (0.4%) | 2,644 (0.6%) |
| Other | 3,656 (3.5%) | 3,962 (2.6%) | 4,887 (2.3%) | 12,505 (2.6%) |
| Unknown (reported) | 430 (0.4%) | 287 (0.2%) | 350 (0.2%) | 1,067 (0.2%) |
| Total ethnicity reported | 77,211 | 106,807 | 129,910 | 313,928 (64.7%)b |
| Hispanic/Latino | 11,698 (15.2%) | 16,632 (15.6%) | 13,406 (10.3%) | 41,736 (13.3%) |
| Not Hispanic/Latino | 64,106 (83.0%) | 86,464 (81.0%) | 111,746 (86.0%) | 262,316 (83.6%) |
| Unknown (reported) | 1,407 (1.8%) | 3,711 (3.5%) | 4,758 (3.7%) | 9,876 (3.1%) |
| Total age group reportedc (year) | 47,312 | 125,171 | 177,581 | 350,064 (72.2%)b |
| <65 | 40,189 (84.9%) | 91,571 (73.2%) | 116,432 (65.6%) | 248,192 (70.9%) |
| ≥65 | 7,123 (15.1%) | 33,600 (26.8%) | 61,149 (34.4%) | 101,872 (29.1%) |
| ≥75d | 570 (1.2%) | 7,658 (6.1%) | 20,011 (11.3%) | 28,239 (8.1%) |
| ≥85e | 7 (<0.1%) | 28 (<0.1%) | 7 (<0.1%) | 42 (<0.1%) |
Excludes sex-specific and pediatric indications (n = 11).
This is the percentage of participants out of the 484,896 total enrollment who reported their information within each demographic subgroup. In subgroups where a higher percentage of participants were not reported, then results of participation should only be based on those reporting their information and should not be extrapolated to the entire population.
The information provided in the applications for age was reported in variable formats. Applications that included a breakdown of participants by <65 years and ≥65 years usually did not further delineate the additional geriatric subgroupings by age ≥75 or ≥85. The numbers included in the table are only for those applications that reported/presented the data in those age groups, and they will underestimate the actual number of patients for the ≥75 and ≥85 year age groups participating in the clinical trials.
≥75 years is a subset of ≥65 years and is included in the ≥65 years age group numbers.
≥85 years is a subset of ≥75 years and is included in both the ≥65 and ≥75 years age group numbers.
AA, African American; AI/AN, American Indian/Alaska Native; CDER, Center for Drug Evaluation and Research; FDA, Food and Drug Administration; NH/OPI, Native Hawaiian/Other Pacific Islander.