Table 2 Clinical trial registration and results reporting policies
From: Clinical trial registration and reporting: a survey of academic organizations in the United States
QUESTION (number of participants who viewed the question) | No. | Percentage |
|---|---|---|
Trial registration policies | ||
Does the organization have a registration policy? (N = 366)a | ||
Yes | 156 | 43% |
No | 173 | 47% |
Don’t know | 37 | 10% |
Does the policy cover investigators joining the organization? (N = 156)b | ||
Yes | 57 | 37% |
No | 76 | 49% |
Don’t know | 23 | 15% |
Skipped (did not answer) | 0 | 0% |
Does the policy cover investigators leaving the organization? (N = 156)b | ||
Yes | 38 | 24% |
No | 87 | 56% |
Don’t know | 31 | 20% |
Skipped (did not answer) | 0 | 0% |
According to the policy, when must trials be registered? (N = 139)b,c | ||
Before IRB approval | 15 | 11% |
Before enrollment begins | 49 | 35% |
Within 21 days of beginning enrollment | 31 | 22% |
Requirements differ among trials | 21 | 15% |
This is not addressed in the policy | 18 | 13% |
Don’t know | 4 | 3% |
Skipped (did not answer) | 1 | 1% |
According to the policy, who is responsible for determining whether a trial must be registered? (N = 129)b,c | ||
Principal investigator | 72 | 56% |
Institutional review board | 20 | 16% |
PRS administrator | 35 | 27% |
Other | 14 | 11% |
This responsibility is not assigned in the policy | 12 | 9% |
Don’t know | 0 | 0% |
Skipped (did not answer) | 0 | 0% |
According to the policy, can investigators be penalized by the organization for failing to register a trial? (N = 139)b | ||
Yes | 27 | 23% |
No | 91 | 91% |
Don’t know | 21 | 21% |
Skipped (did not answer) | 0 | 0% |
Date the trial registration policy came into effect (N = 139)b,d | ||
Minimum (year) | 2000 | |
Maximum (year) | 2016 | |
Median (year) | 2013 | |
Results reporting policies | ||
Does the organization have a results reporting policy? (N = 366)a | ||
Yes | 129 | 35% |
No | 193 | 53% |
Don’t know | 44 | 12% |
According to the policy, who is responsible for monitoring if results are reported on time? (N = 115)b,c | ||
Principal investigator | 54 | 47% |
Institutional review board | 5 | 4% |
PRS administrator | 68 | 59% |
Other | 12 | 10% |
This responsibility is not assigned in the policy | 18 | 16% |
Don’t know | 1 | 1% |
Skipped (did not answer) | 0 | 0% |
According to the policy, can investigators be penalized by the organization for failing to report a trial (N = 114)e | ||
Yes | 21 | 18% |
No | 75 | 66% |
Don’t know | 18 | 16% |
Skipped (did not answer) | 0 | 0% |