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Table 1 Characteristics of included clinical trials

From: Towards full clinical trial registration and results publication: longitudinal meta-research study in Northwestern and Central Switzerland

Characteristics

Categories

All trials (n = 473)

Investigator-sponsored trials (n = 342)

Industry-sponsored trials (n = 131)

Target sample size in Switzerland (median, IQR)

32 (16-75)

45 (22-100)

15 (8-28)

Trial intervention, n (%)

Drugs

215 (45.5)

116 (33.9)

99 (75.6)

Medical devices

96 (20.3)

69 (20.2)

27 (20.6)

Behavioral

33 (7.0)

33 (9.6)

0 (0.0)

Diagnostic

28 (5.9)

26 (7.6)

2 (1.5)

Rehabilitation

23 (4.9)

23 (6.7)

0 (0.0)

Dietary supplements

18 (3.8)

18 (5.3)

0 (0.0)

Surgical

16 (3.4)

15 (4.4)

1 (0.8)

Otherb

44 (9.3)

42 (12.3)

2 (1.5)

Trial design, n (%)

Single arm

121 (25.6)

78 (22.8)

43 (32.8)

Multiple armsc

352 (74.4)

264 (77.2)

88 (67.2)

Randomized

323 (68.3)

239 (69.9)

84 (64.1)

Non randomized

29 (6.1)

25 (7.3)

4 (3.1)

Risk categorya, n (%)

Low risk

238 (50.3)

220 (64.3)

18 (13.7)

Intermediate risk

83 (17.6)

71 (20.8)

12 (9.2)

High risk

152 (32.1)

51 (14.9)

101 (77.1)

Trial sites, n (%)

Single Center

255 (53.9)

243 (71.1)

12 (9.2)

Multicenter

218 (46.1)

99 (28.9)

119 (90.8)

National

46 (9.7)

43 (12.6)

3 (2.3)

International

172 (36.4)

56 (16.4)

116 (88.5)

Use of CTU service, n (%)

104 (22.0)

104 (30.4)

0 (0.0)

  1. Abbreviation: IQR interquartile range 25% percentile - 75% percentile, CTU Clinical Trials Unit
  2. aClassification of studies in the Human Research Act: Category A – low risk for trials with products authorized in Switzerland, and used according to Swiss Summary of Product Characteristics; Category B - intermediate risk for trials with products authorized in Switzerland, not used according to Swiss Summary of Product Characteristics; Category C - high risk for trials with products not authorized in Switzerland. Intermediate and high risk categories require additional authorization by federal authority (Swissmedic) [ 30]
  3. bIncludes: exercise trials, physiotherapy, transplant products, PK/PD safety trials, radiation therapy, palliation, other diet trials
  4. c Includes cross-over (n = 71), parallel group (n = 278), factorial (n = 3)