Table 3.
Characteristics of studies with PFS as primary endpoint and positive results
| Trials with positive PFS (EP1) (N = 182) |
QoL results (global QoL), n (%) |
||||
|---|---|---|---|---|---|
| Not available | Without statistically significant difference | Unfavourable | Positive | Chi-square test | |
| Studies with positive PFS | 57 (31.3) | 78 (42.9) | 2 (1.1) | 45 (24.7) | — |
| Journal IF | |||||
| Journals with high IF | 28 (23.1) | 56 (46.3) | 2 (1.7) | 35 (28.9) | P = 0.006 |
| Journals with low/intermediate IF | 29 (47.5) | 22 (36.1) | 0 (0) | 10 (16.4) | |
| Years of primary publication | |||||
| Studies published in 2012-2016 | 26 (32.9) | 33 (41.8) | 0 (0) | 20 (25.3) | P = 0.636 |
| Studies published in 2017-2021 | 31 (30.1) | 45 (43.7) | 2 (1.9) | 25 (24.3) | |
| Masking | |||||
| Open label | 35 (35.0) | 34 (34.0) | 1 (1.0) | 30 (30.0) | P = 0.057 |
| Blinded | 22 (26.8) | 44 (53.7) | 1 (1.2) | 15 (18.3) | |
| Sponsorship | |||||
| Industry-sponsored | 38 (25.7) | 66 (44.6) | 1 (0.7) | 43 (29.1) | P = 0.001 |
| Academic | 19 (55.9) | 12 (35.3) | 1 (2.9) | 2 (5.9) | |
| Type of tumour | |||||
| Breast | 14 (36.8) | 14 (36.8) | 0 (0) | 10 (26.3) | P = 0.494 |
| GI | 10 (34.5) | 16 (55.2) | 0 (0) | 3 (10.3) | |
| GU | 3 (16.7) | 9 (50.0) | 0 (0) | 6 (33.3) | |
| Thoracic | 13 (28.3) | 16 (34.8) | 1 (2.2) | 16 (34.8) | |
| Other | 17 (33.3) | 23 (45.1) | 1 (2.0) | 10 (19.6) | |
| Type of experimental treatment | |||||
| Chemotherapy ± other | 16 (61.5) | 8 (30.8) | 0 (0) | 2 (7.7) | P = 0.051 |
| Targeted therapy ± other | 29 (28.7) | 43 (42.6) | 2 (2.0) | 27 (26.7) | |
| Hormonal therapy ± other | 5 (22.7) | 12 (54.5) | 0 (0) | 5 (22.7) | |
| Immunotherapy ± other | 7 (21.2) | 15 (45.5) | 0 (0) | 11 (33.3) | |
EP1, primary endpoint; GI, gastrointestinal; GU, genitourinary; IF, impact factor; PFS, progression-free survival; QoL, quality of life.