From: Access to unpublished protocols and statistical analysis plans of randomised trials
High impact cohort | PubMed cohort | Total | |
---|---|---|---|
Publicly available protocol in stage 1 | |||
Yes (excluded from stage 2) | 90/101 (89) | 15/100 (15) | 105/201 (52) |
No (included in stage 2) | 11/101 (11) | 85/100 (85) | 96/201 (48) |
Replied to email requesting protocol/SAP | |||
Yes | 6/11 (55) | 9/85 (11) | 15/96 (16) |
No | 5/11 (45) | 76/85 (89) | 81/96 (84) |
Days until first response (among those responding) | |||
Median (IQR) | 23 (4, 35) | 3 (2, 21) | 10 (2, 35) |
Shared some study documents | |||
Yes | 4/11 (36) | 4/85 (5) | 8/96 (8) |
No | 7/11 (64) | 81/85 (95) | 88/96 (92) |
Days until documents shared (among those sharing) | |||
Median (IQR) | 31 (14, 42) | 21 (11, 22) | 22 (11, 31) |
Shared protocol | |||
Yes | 4/11 (36) | 2/85 (2) | 6/96 (6) |
No | 7/11 (64) | 83/85 (98) | 90/96 (94) |
Shared statistical analysis plan | |||
Yes | 1/11 (9) | 0/85 (0) | 1/96 (1) |
No | 10/11 (91) | 85/85 (0) | 95/96 (99) |
Shared other study documentsa | |||
Yes | 0/11 (0) | 2/85 (2) | 2/96 (2) |
No | 11/11 (100) | 83/85 (98) | 94/96 (98) |
Study protocol available at end of stage 2 (either available publicly in stage 1 or shared upon request in stage 2) | |||
Yes | 94/101 (93) | 17/100 (17) | 111/201 (55) |
No | 7/101 (7) | 83/100 (83) | 90/201 (45) |