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Table 2 Results from included trials

From: Are investigators’ access to trial data and rights to publish restricted and are potential trial participants informed about this? A comparison of trial protocols and informed consent materials

 

Total (n = 42)

Partially industry sponsored (n = 10)

Fully industry sponsored (n = 32)

Roles and responsibilities of sponsor described

 Yes

20 trials (48%)

6 trials (60%)

45 trials (44%)

 No

22 trials (52%)

4 trials (40%)

18 trials (56%)

Owner of data accumulated during the trial

 Sponsor

20 trials (48%)

1 trial (10%)

19 trials (59%)

 Investigator

6 trials (14%)

6 trials (60%)

0 trials (0%)

 Unclear

16 trials (38%)

3 trials (30%)

13 trials (41%)

Sponsor had the opportunity to review data during trial

 Yes

8 trials (19%)

0 trials (0%)

8 trials (25%)

 No

14 trials (33%)

7 trials (70%)

7 trials (22%)

 Unclear

20 trials (48%)

3 trials (30%)

17 trials (53%)

Sponsor had the opportunity to stop the trial early

 Yes, for any reason

23 trials (55%)

0 trials (0%)

23 trials (72%)

 Yes, but only for specific reasons

4 trials (9%)

0 trials (0%)

4 trials (13%)

 No

7 trials (17%)

6 trials (60%)

1 trial (3%)

 Unclear

8 trials (19%)

4 trials (40%)

4 trials (12%)

Rights to publish were constricted

 Yes

30 trials (71%)

1 trial (10%)

29 trials (91%)

 No

7 trials (17%)

7 trials (70%)

0 trials (0%)

 Unclear

5 trials (12%)

2 trials (20%)

3 trials (9%)

Publication constraints mentioned in ICDs (n = 30)

 Yes

0/30 trials (0%)

0/1 trial (0%)

0/29 trials (0%)

 No

30/30 trials (100%)

1/1 trial (100%)

29/29 trials (100%)