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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) |
