CT design
|
Randomised, controlled (including cluster- and community-randomised)
|
37
|
(84.1)
|
Control
|
Placebo-controlled
|
12
|
(32.4)
|
Treatment-controlled
|
24
|
(64.9)
|
No treatment-controlled
|
1
|
(2.7)
|
Blinding
|
Blinded (including double-, single-, and partially-blinded)
|
21
|
(56.8)
|
Open-label
|
10
|
(27.0)
|
NDA
|
6
|
(16.2)
|
Phase
|
Phase I
|
1
|
(2.7)
|
Phase III
|
3
|
(8.1)
|
NDA
|
33
|
(89.2)
|
Non-randomised, single-arm
|
6
|
(13.6)
|
NDA
|
1
|
(2.3)
|
EC/ IRB approval
|
By multiple national and external ECs/IRBs (local regulatory authorities, local IRBs, national ECs, international ECs, external national ECs, and external IRBs)
|
24
|
(54.5)
|
By multiple local (local regulatory authorities, local IRBs, national ECs)
|
1
|
(2.3)
|
Only by local EC/IRB
|
13
|
(29.5)
|
Only by national EC
|
1
|
(2.3)
|
NDA
|
5
|
(11.4)
|
Regulatory/ethical guidancea
|
Good Clinical Practice
|
13
|
(29.5)
|
Declaration of Helsinki
|
9
|
(20.5)
|
National/local regulatory requirements
|
7
|
(15.9)
|
Good Laboratory Practice
|
1
|
(2.3)
|
n/a (Conference abstract)
|
2
|
(4.5)
|
NDA
|
27
|
(61.4)
|
Supplementary materiala
|
CT registrationb
|
21
|
(47.7)
|
CT publications including supplementary files
|
9
|
(20.5)
|
Protocol as supplementary filec
|
6
|
(13.6)
|
CT publication sections and files addressing ICa
|
Abstract
|
18
|
(40.9)
|
Methods
|
41
|
(93.2)
|
Eligibility
|
27
|
(65.9)
|
Ethics
|
34
|
(82.9)
|
Results
|
15
|
(34.1)
|
Discussion
|
1
|
(2.3)
|