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Table 1 Characteristics of the 391 completed studies with follow-up questionnaire returned

From: Patient enrollment and logistical problems top the list of difficulties in clinical research: a cross-sectional survey

  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)