Table 2. Summary Statistics for All 2020 Drug Approvals Compared With Oncology Subseta.
| Characteristic | 2020 Drug approvals | 2020 Nononcology approvals | 2020 Oncology approvals | P valueb |
|---|---|---|---|---|
| Total drugs, No. | 49 | 32 | 17 | NA |
| Total pivotal trials, No. | 75 | 57 | 18 | NA |
| Pivotal trials per drug, median (range) | 1 (1-4) | 2 (1-4) | 1 (1-2) | NA |
| Design characteristics, by trial, No./total No. (%) | ||||
| Partial or complete randomization | 57/75 (76.0) | 51/57 (89.5) | 6/18 (33.3) | <.001 |
| Double masking | 46/75 (61.3) | 44/57 (77.2) | 2/18 (11.1) | <.001 |
| Surrogate end point | 34/75 (45.3) | 17/57 (29.8) | 17/18 (94.4) | <.001 |
| Design characteristics, by drug, No./total No. (%) | ||||
| Randomization | 36/49 (73.5) | 30/32 (93.8) | 6/17 (35.3) | <.001 |
| Double masking | 28/49 (57.1) | 26/32 (81.3) | 2/17 (11.8) | <.001 |
| Surrogate end point | 28/49 (57.1) | 12/32 (37.5) | 16/17 (94.1) | <.001 |
| Comparator, by trial | ||||
| Placebo or vehicle control | 39/75 (52.0) | 38/57 (66.7) | 1/18 (5.6) | <.001 |
| Active control | 13/75 (17.3) | 10/57 (17.5) | 3/18 (16.7) | .93 |
| Placebo and active control | 2/75 (2.7) | 1/57 (1.8) | 1/18 (5.6) | .38 |
| Historical, external, or other control | 21/75 (28.0) | 8/57 (14.0) | 13/18 (72.2) | <.001 |
Abbreviation: NA, not applicable.
a
Cohort excludes 4 novel diagnostic agents approved by the US Food and Drug Administration in 2020.
b
The χ2 test was used to compare the differences between the nononcology and oncology approval groups.