Table 3.
Comparison of combination trials and non-combination trials in oncology and non-oncology
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|---|---|---|---|
| Non-Oncology Combination | Oncology Combination | Oncology Non-Combination | |
| Funded By(a) | n=4480 | n=3753 | n=10899 |
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| |||
| Industry | 3086 (68.9%) | 1839 (49.0%) | 3946 (36.2%) |
| NIH | 230 (5.1%) | 853 (22.7%) | 1205 (11.1%) |
| Other | 1654 (36.9%) | 2318 (61.8%) | 8195 (75.2%) |
| U.S. Fed | 39 (0.9%) | 14 (0.4%) | 90 (0.8%) |
|
| |||
| Primary Purpose | n=4217 | n=3732 | n=10545 |
|
| |||
| Basic Science | 236 (5.6%) | 13 (0.3%) | 148 (1.4%) |
| Diagnostic | 44 (1.0%) | 12 (0.3%) | 858 (8.1%) |
| Health Services Research | 9 (0.2%) | 1 (0.03%) | 97 (0.9%) |
| Prevention | 458 (10.9%) | 34 (0.9%) | 508 (4.8%) |
| Screening | 6 (0.1%) | 3 (0.08%) | 145 (1.4%) |
| Supportive Care | 43 (1.0%) | 30 (0.8%) | 597 (5.7%) |
| Treatment | 3421 (81.1%) | 3639 (97.5%) | 8192 (77.7%) |
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| |||
| Endpoint Measures | n=4179 | n=3311 | n=9202 |
|
| |||
| Bio-availability Study | 63 (1.5%) | 4 (0.1%) | 24 (0.3%) |
| Bio-equivalence Study | 95 (2.3%) | 0 (0%) | 52 (0.6%) |
| Efficacy Study | 809 (19.4%) | 795 (24.0%) | 3051 (33.2%) |
| Pharmacodynamics | 78 (1.9%) | 7 (0.2%) | 86 (0.9%) |
| Pharmacokinetics | 425 (10.2%) | 24 (0.7%) | 103 (1.1%) |
| Pharmacokinetics/Dynamics | 137 (3.3%) | 12 (0.4%) | 71 (0.8%) |
| Safety Study | 437 (10.7%) | 492 (14.9%) | 947 (10.3%) |
| Safety/Efficacy Study | 2135 (51.1%) | 1977 (59.7%) | 4868 (52.9%) |
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| |||
| Allocation | n=4176 | n=2413 | n=6142 |
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| |||
| Non-Randomized | 563 (13.5%) | 795 (33.0%) | 2189 (35.6%) |
| Randomized | 3613 (86.5%) | 1618 (67.0%) | 3953 (64.4%) |
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| |||
| Phase | n=4134 | n=3634 | n=8530 |
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| |||
| Phase 0 | 12 (0.3%) | 15 (0.4%) | 180 (2.1%) |
| Phase 1 | 1114 (27.0%) | 778 (21.4%) | 1657 (19.4%) |
| Phase 1/Phase 2 | 133 (3.2%) | 582 (16.0%) | 896 (10.5%) |
| Phase 2 | 851 (20.6%) | 1655 (45.5%) | 3950 (46.3%) |
| Phase 2/Phase 3 | 88 (2.1%) | 52 (1.4%) | 201 (2.4%) |
| Phase 3 | 1136 (27.5%) | 499 (13.7%) | 1183 (13.9%) |
| Phase 4 | 800 (19.4%) | 53 (1.5%) | 463 (5.4%) |
The sum of percentages exceed 100 because trials may be funded by more than agencies