|
Items
|
Definition
|
All cases completed
|
Not all cases completed
|
p value
|
|---|
|
n = 95
|
n = 47
|
|---|
| | |
n (%)
|
n (%)
| |
|
Clinical trial with an agreed PIP
|
Yes
|
18 (18.9)
|
13 (27.7)
|
0.24
|
|
Sponsor type
|
Commercial
|
87 (91.6)
|
47 (100.0)
|
0.10
|
|
Clinical trial with substantial protocol amendments
|
Yes
|
71 (74.7)
|
31 (66.6)
|
0.27
|
|
Clinical trial with no protocol amendments after starting trials
|
Yes
|
41 (43.2)
|
20 (42.6)
|
0.94
|
|
Global interruptions of the clinical trial
|
Yes
|
NA
|
7 (14.9)
|
NA
|
|
Clinical trial status
|
|
Not authorized
|
Yes
|
NA
|
4 (8.5)
|
NA
|
|
Temporarily halted
|
Yes
|
NA
|
2 (4.3)
|
NA
|
|
Prematurely ended
|
Yes
|
NA
|
43 (91.5)
|
NA
|
- p values; chi-square test for categorical variables
- Note: PIP pediatric investigation plan, NA not applicable. Not authorized: Pediatric trials for which a negative ethics committee opinion was issued. Since a trial with a negative ethics committee opinion cannot proceed, these are labeled as not authorized. Temporarily halted: A trial that has been temporarily interrupted
- Prematurely ended: A trial that has ended without completing all events described in the protocol. Reasons for a premature end can be related to lack of product safety or efficacy, or lack of feasibility of the trial
