Table 1 Study characteristics for randomized cancer clinical trials
From: Public access to protocols of contemporary cancer randomized clinical trials
| Â | RCTs with protocols, n=48 | RCTs without protocols, n=85 |
|---|---|---|
Sample size, median (range) | 203 (7–13,195) | 102 (6–3864) |
Type of cancer, n (%) | ||
 Central nervous system | 0 | 3 (3.5) |
 Head and neck | 3 (6.2) | 5 (5.9) |
 Gastrointestinal | 7 (14.6) | 21 (24.7) |
 Lung | 6 (12.5) | 6 (7.1) |
 Genitourinary | 11 (22.9) | 13 (15.3) |
 Breast | 9 (18.8) | 20 (23.5) |
 Leukemia/lymphoma | 5 (10.4) | 6 (7.1) |
 Melanoma | 1 (2.1) | 2 (2.3) |
 Soft tissue sarcoma | 1 (2.1) | 1 (1.2) |
 Thyroid | 0 | 1 (1.2) |
 Multiple | 5 (10.4) | 7 (8.2) |
Study type, n(%) | ||
 Cancer-directed therapy | 25 (52.1) | 29 (34.1) |
 Supportive care | 17 (35.4) | 44 (51.8) |
 Imaging | 1 (2.1) | 2 (2.4) |
 Preventative/screening | 2 (4.2) | 6 (7.0) |
 Surgical/anesthesia | 1 (2.1) | 4 (4.7) |
 Other | 2 (4.2) | 0 |
Primary endpointa, n(%) | ||
 Overall survival | 4 (7.4) | 9 (10.1) |
 Event-free survival | 15 (27.8) | 15 (16.9) |
 Response rate | 4 (7.4) | 6 (6.7) |
 Symptom management | 14 (25.9) | 28 (31.5) |
 Other | 17 (31.5) | 25 (28.1) |
 Not specified | 0 | 6 (6.7) |
Single primary endpoint | 42 (87.5) | 75 (88.2) |
Co-primary endpoints | 6 (12.5) | 4 (4.7) |
Trial phase, n (%) | Â | Â |
 III | 21 (43.8) | 18 (21.2) |
 II | 10 (20.8) | 26 (30.6) |
 Not specified | 17 (35.4) | 41 (48.2) |
Source of funding | ||
 Industry | 14 (29.2) | 18 (21.2) |
 Academic/public | 27 (56.2) | 53 (62.3) |
 None listed | 7 (14.6) | 14 (16.5) |