Table 1 Characteristics of the 391 completed studies with follow-up questionnaire returned
N (%) | |
|---|---|
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) |