Table 1 Characteristics of the 36 ovarian cancer RCTs
Characteristic | No. of RCTs (%) | |
|---|---|---|
Publication in which PRO results published | Main RCT publication | 18 (50) |
Dedicated publication | 10 (28) | |
PROs not published | 3 (8) | |
Year of main RCT publication | 2000–2009 | 15 (42) |
2010–2016 | 21 (58) | |
Year of dedicated PRO publication | 2000–2009 | 4 (11) |
2010–2016 | 6 (17) | |
No dedicated QOL publication | 26 (72) | |
PRO endpoint status | Co-primary | 1 (3) |
Secondary | 33 (96) | |
Tertiary | 1 (3) | |
Unclear | 1 (3) | |
PRO measures used | EORTC QLQ-C30 a | 24 (67) |
EORTC QLQ-OV28 b | 12 (33) | |
FACT-O c | 11 (13) | |
Other FACIT d measures | 4 (11) | |
EQ-5D e | 4 (12) | |
Other | 3 (8) | |
Sig. difference in primary RCT endpoint | Yes f | 15 (42) |
No | 21 (81) | |
Sig. difference in any PRO scale reported | Yes f | 19 (53) |
No | 14 (39) | |
Unclear, as no PRO results reported | 3 (8) | |
Intervention | Chemotherapy | 28 (78) |
Targeted therapy | 7 (19) | |
Surgery | 2 (6) | |
Primary endpoint | Progression-free survival (PFS) | 21 (58) |
Overall survival | 5 (14) | |
Survival (other) | 3 (8) | |
All-cause mortality | 2 (6) | |
Time to progression | 2 (6) | |
PFS and QOL (co-primary) | 1 (3) | |
Sponsors | Clinical Trials Group | 25 (69) |
Commercial/pharmaceutical | 7 (19) | |
Co-sponsored: Trials group and commercial | 4 (11) | |