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Table 2 Study results

From: Access to unpublished protocols and statistical analysis plans of randomised trials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)

  1. aPartial excerpt from a protocol (n = 1), research ethics application form (n = 1)