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Table 7 Technical characteristics of approved protocols

From: The activity of French Research Ethics Committees and characteristics of biomedical research protocols involving humans: a retrospective cohort study

 

n

%

Topic

  

Drug

667

68.3

   Phase I

163

24.4

   Phase II

173

25.9

   Phase III

226

33.9

   Phase IV

105

15.7

Cosmetics and nutrition

50

5.1

Physiology

65

6.7

Medical equipment & prothesis

64

6.6

Surgical and/or diagnostic act

52

5.3

Other

78

8.0

Design

  

Descriptive, analytic

150

15.4

Experimental, non-randomized

319

32.7

Experimental, randomized

507

51.9

Scope

  

National-monocentric

463

47.4

National-multicentric

311

31.9

International

161

16.5

Not available

41

4.2

Expected sample size

  

Fewer than 21 patients

293

30.0

21 to 50 patients

251

25.7

51 to 150 patients

192

19.7

More than 150 patients

228

23.4

Not available

12

1.2

Expected duration

  

Less than 2 months

115

11.8

2 to 6 months

159

16.3

6 to 18 months

286

29.3

More than 18 months

163

16.7

Not available

253

25.9