| Funder/sponsor |
Private |
16(47%) |
19(56%) |
35(51%) |
| |
Public |
8(24%) |
11(32%) |
19(28%) |
| |
Private and Public |
4(12%) |
4(12%) |
8(12%) |
| |
None/independent |
1(3%) |
0(0%) |
1(1%) |
| |
Undisclosed |
5(15%) |
0(0%) |
5(7%) |
| Nature of primary outcome(s) |
Time-to-event |
23(68%) |
28(82%) |
51(75%) |
| |
Binary |
6(18%) |
3(9%) |
9(13%) |
|
Continuous |
3(9%) |
3(9%) |
6(9%) |
| |
Binary and continuous |
1(3%) |
0(0%) |
1(1%) |
| |
Binary and time-to-event |
1(3%) |
0(0%) |
1(1%) |
| Number of intervention arms |
2 |
26(76%) |
29(85%) |
55(81%) |
| |
3 |
6(18%) |
3(9%) |
9(13%) |
| |
4 |
1(3%) |
1(3%) |
2(3%) |
| |
5 or 6 |
1(3%) |
1(3%) |
2(3%) |
| Therapeutic area |
Oncology |
28(82%) |
24(71%) |
52(76%) |
|
HIV/AIDS |
3(9%) |
0(0%) |
3(4%) |
|
Cardiac |
0(0%) |
2(6%) |
2(3%) |
|
Musculoskeletal |
1(3%) |
1(3%) |
2(3%) |
|
Optical |
0(0%) |
2(6%) |
2(3%) |
| |
Stroke |
0(0%) |
1(3%) |
1(1%) |
| |
Respiratory |
1(3%) |
0(0%) |
1(1%) |
| |
Diabetes |
0(0%) |
1(3%) |
1(1%) |
| |
Multiple Sclerosis |
1(3%) |
0(0%) |
1(1%) |
| |
Degenerative |
0(0%) |
1(3%) |
1(1%) |
| |
Epilepsy |
0(0%) |
1(3%) |
1(1%) |
| |
Kidney |
0(0%) |
1(3%) |
1(1%) |
| Journal CONSORT endorsement status |
No |
13(38%) |
9(26%) |
22(32%) |
| |
Yes |
21(62%) |
25(74%) |
46(68%) |
| Publishing journal |
The Lancet Oncology |
3(9%) |
9(26%) |
12(18%) |
|
The New England Journal of Medicine |
5(15%) |
7(21%) |
12(18%) |
| |
American Society of Clinical Oncology |
8(24%) |
4(12%) |
12(18%) |
| |
Annals of Oncology |
3(9%) |
2(6%) |
5(7%) |
|
The Journal of the American Medical Association |
1(3%) |
4(12%) |
5(7%) |
|
Breast Cancer Research Treatment |
2(6%) |
1(3%) |
3(4%) |
|
Journal of Clinical Oncology |
2(6%) |
1(3%) |
3(4%) |
|
The Lancet |
1(3%) |
1(3%) |
2(3%) |
|
The American Academy of Ophthalmology |
0(0%) |
2(6%) |
2(3%) |
| |
Arthritis and Rheumatology |
0(0%) |
1(3%) |
1(1%) |
| |
British Journal of Surgery |
1(3%) |
0(0%) |
1(1%) |
| |
Clinical Breast Cancer |
0(0%) |
1(3%) |
1(1%) |
| |
Clinical Cancer Research |
1(3%) |
0(0%) |
1(1%) |
| |
European Journal of Cancer |
0(0%) |
1(3%) |
1(1%) |
| |
HIV Clinical Trials |
1(3%) |
0(0%) |
1(1%) |
| |
Journal of the National Cancer Institute |
1(3%) |
0(0%) |
1(1%) |
| |
Journal of Urology |
1(3%) |
0(0%) |
1(1%) |
| |
Journal of the National Cancer Institute |
1(3%) |
0(0%) |
1(1%) |
| |
Nutrition |
1(3%) |
0(0%) |
1(1%) |
| |
Radiotherapy and Oncology |
1(3%) |
0(0%) |
1(1%) |
| |
The Journal of Infectious Diseases |
1(3%) |
0(0%) |
1(1%) |
| Type of intervention |
Drug |
29(85%) |
30(88%) |
59(87%) |
|
Dietary |
1(3%) |
1(3%) |
2(3%) |
| |
Device |
0(0%) |
1(3%) |
1(1%) |
| |
Physiological |
1(3%) |
0(0%) |
1(1%) |
| |
Radiotherapy |
1(3%) |
0(0%) |
1(1%) |
| |
Drug and radiotherapy |
0(0%) |
1(3%) |
1(1%) |
| |
Drug and dietary |
1(3%) |
0(0%) |
1(1%) |
| |
Surgical |
1(3%) |
0(0%) |
1(1%) |
| |
Vaccine |
0(0%) |
1(3%) |
1(1%) |
| Class of intervention |
Pharmacological |
30(88%) |
32(94%) |
62(91%) |
| |
Non-pharmacological |
4(12%) |
2(6%) |
6(9%) |
| Stage of reporting |
Interim analysis |
25(74%) |
22(65%) |
47(69%) |
| |
Final analysis |
7(21%) |
6(18%) |
13(19%) |
| |
Unplanned interim analysis |
2(6%) |
6(18%) |
8(12%) |
| Number of planned interims |
1 |
16(47%) |
12(35%) |
28(41%) |
| |
2 |
9(26%) |
14(41%) |
23(34%) |
| |
3 |
3(9%) |
2(6%) |
5(7%) |
| |
4 |
0(0%) |
4(12%) |
4(6%) |
|
5 or 7 |
3(9%) |
0(0%) |
3(4%) |
| |
Undisclosed |
3(9%) |
2(6%) |
5(7%) |
| Trials stopped early |
No |
11(32%) |
9(26%) |
20(29%) |
| |
Yes |
22(65%) |
24(71%) |
46(68%) |
| |
No, but interim arm discontinued at interim |
1(3%) |
1(3%) |
2(3%) |
| Reasons for early stopping (N = 46) |
Futility |
12(55%) |
10(42%) |
22(48%) |
| |
Efficacy |
5(23%) |
5(21%) |
10(22%) |
| |
Safety |
1(5%) |
1(4%) |
2(4%) |
| |
Futility and safety |
0(0%) |
5(21%) |
5(11%) |
| |
Poor recruitment and/or financial |
3(14%) |
3(13%) |
6(13%) |
| |
Futility and external information |
1(5%) |
0(0%) |
1(2%) |
| Planned stopping criteria |
Undisclosed |
16(47%) |
6(18%) |
22(32%) |
|
Futility or efficacy |
8(24%) |
12(35%) |
20(29%) |
| |
Futility |
3(9%) |
6(18%) |
9(13%) |
| |
Efficacy |
0(0%) |
6(18%) |
6(9%) |
| |
Efficacy or safety |
3(9%) |
1(3%) |
4(6%) |
| |
Futility or efficacy or safety |
1(3%) |
3(9%) |
4(6%) |
|
Non-inferiority |
2(6%) |
0(0%) |
2(3%) |
| |
Safety |
1(3%) |
0(0%) |
1(1%) |
| Planned total sample size |
Min to Max |
160–8028 |
100–15000 |
100–15000 |
| |
Median(IQR) |
604(350–1071) |
784(428–1200) |
724(357–1155) |
