Table 1. Characteristics of Phase 3 Cancer Treatment Clinical Trials at SWOG.
| Characteristic | No. (%) of Trials | P Valueb | |
|---|---|---|---|
| All (n = 182) | Practice Influential (n = 82)a | ||
| Cancer type | |||
| Brain | 7 (3.8) | 0 | .02 |
| Breast | 30 (16.5) | 7 (23.3) | |
| Gastrointestinal tract | 22 (12.1) | 13 (59.1) | |
| Genitourinary | 26 (14.3) | 16 (61.5) | |
| Gynecologic | 11 (6.0) | 5 (45.5) | |
| Head and neck | 7 (3.8) | 5 (71.4) | |
| Leukemia | 17 (9.3) | 6 (35.3) | |
| Lung | 23 (12.6) | 9 (39.1) | |
| Lymphoma | 12 (6.6) | 6 (50.0) | |
| Melanoma | 12 (6.6) | 6 (50.0) | |
| Myeloma | 8 (4.4) | 4 (50.0) | |
| Others | 7 (3.8) | 5 (71.4) | |
| Disease setting | |||
| Adjuvant | 62 (34.1) | 27 (43.5) | .77 |
| Advanced | 120 (65.9) | 55 (45.8) | |
| Design type | |||
| Superiority | 176 (96.7) | 77 (43.8) | .09 |
| Equivalence or noninferiority | 6 (3.3) | 5 (83.3) | |
| End point type | |||
| Overall survival | 39 (21.4) | 19 (48.7) | .80 |
| Multiple, including overall survival | 131 (72.0) | 57 (43.5) | |
| Other | 12 (6.6) | 6 (50.0) | |
| No. of intervention arms | |||
| 2 | 119 (65.4) | 53 (44.5) | .85 |
| >2 | 63 (34.6) | 29 (46.0) | |
| Interventionc | |||
| Systemic therapy | 177 (97.3) | 80 (45.2) | >.99 |
| Biological therapy | 23 (12.6) | 10 (43.5) | .87 |
| Surgery | 20 (11.0) | 10 (50.0) | .64 |
| Radiotherapy | 43 (23.6) | 22 (51.2) | .36 |
| Transplant | 13 (7.1) | 5 (38.5) | .62 |
| Blinded treatment | 8 (4.4) | 0 | .009 |
| Total accruald | |||
| Above the median | 91 (50.0) | 38 (41.8) | .37 |
| Below the median | 91 (50.0) | 44 (48.4) | |
| Trial result | |||
| Positive | 65 (35.7) | 47 (72.3) | <.001 |
| Null or negative | 117 (64.3) | 35 (29.9) | |
| Intergroup trial | |||
| Yes | 131 (72.0) | 68 (51.9) | .003 |
| No | 51 (28.0) | 14 (27.5) | |
| Decade of trial completion | |||
| 1980-1989 | 29 (15.9) | 9 (31.0) | .01 |
| 1990-1999 | 85 (46.7) | 35 (41.2) | |
| 2000-2009 | 55 (30.2) | 33 (60.0) | |
| 2010 and later | 13 (7.1) | 5 (38.5) | |
Abbreviation: SWOG, (formerly) Southwest Oncology Group.
a
Calculated as percentage of all trials with the characteristic.
b
Calculated as difference in rates of PI trials between study characteristics of PI and non-PI trials using χ2 tests or Fisher exact test where any cell counts were less than 5 for categorical variables and 2-sample t tests for continuous variables.
c
Categories are not mutually exclusive.
d
Median number of patients was 463 (range, 60-7576).