|
Study design
| |
|
Interventional
|
180 (46.0)
|
|
Observational
|
211 (54.0)
|
|
First decision of the research ethics committee (N = 390)
| |
|
Positive, positive with recommendations, or positive with written modifications required
|
309 (79.2)
|
|
Positive with conditions and reassessment, or negative and non-considered, but approved at a later stage
|
81 (20.8)
|
|
Financial sponsorship of the study protocol (N = 377)
| |
|
Public (hospital, university)
|
294 (78.0)
|
|
Private (industry, foundation)
|
75 (19.9)
|
|
Both
|
8 (2.1)
|
|
Link with the industry (N = 378)
| |
|
None
|
267 (70.6)
|
|
Industry with indication of support (funding, drugs, human resources)
|
103 (27.2)
|
|
Industry without indication of support
|
8 (2.1)
|
|
Sample size (N = 390)
| |
|
≤ 100
|
220 (56.4)
|
|
> 100
|
170 (43.6)
|
|
Sample size calculation (N = 384)
| |
|
Yes
|
169 (44.0)
|
|
No
|
215 (56.0)
|
|
Number of centers
| |
|
Single
|
232 (59.3)
|
|
Multicenter
|
159 (40.7)
|
|
Research topic
| |
|
Health or illness (organs, tissues, cells, receptors, etc.)
|
91 (23.3)
|
|
Intervention or treatment
|
172 (44.0)
|
|
Diagnostics method
|
25 (6.4)
|
|
Prognosis
|
12 (3.1)
|
|
Public health, health economics, medical ethic, attitudes
|
43 (11.0)
|
|
Research methods (questionnaires, indicators, measures, etc.)
|
41 (10.5)
|
|
Other, unspecified topic (registries, medical record databases)
|
7 (1.8)
|
|
Clinical specialty
| |
|
General
|
60 (15.3)
|
|
Psychiatry
|
40 (10.2)
|
|
Cardiology
|
35 (9.0)
|
|
Oncology
|
30 (7.7)
|
|
Infectious diseases
|
27 (6.9)
|
|
Neurology
|
16 (4.1)
|
|
Rheumatology
|
7 (1.8)
|
|
Other clinical specialties
|
149 (38.1)
|
|
Two or more specialties
|
27 (6.9)
|
|
Presence of a statistician in the study team (N = 384)
| |
|
Yes
|
98 (25.5)
|
|
No
|
286 (74.5)
|
|
PI’s training in quantitative methods
| |
|
None
|
164 (41.9)
|
|
Courses and/or continuing education at the University level
|
183 (46.8)
|
|
Bachelor, master or PhD in quantitative methods
|
8 (2.0)
|
|
Bachelor, master, or PhD in quantitative methods, and courses/continuing education
|
36 (9.2)
|
|
Study published
| |
|
Yes
|
269 (68.8)
|
|
No
|
122 (31.2)
|
