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Table 3 Percentage of compliance of trial records according to WHO criteria by trial registry.

From: Compliance of clinical trial registries with the World Health Organization minimum data set: a survey

 

Registries (number of records)

 

International

National

Specialty

Pharma

  

Criteria requested

ISCRTN (n = 100)

CT (n = 100)

ACTR (n = 50)

UK NRR (n = 50)

PDQ (n = 33)

STD (n = 33)

RT (n = 33)

R (n = 8)

GSK (n = 72)

N (n = 4)

CSR (n = 37)

Local (n = 90)

Total, % (95% CI)

   Unique trial number

100

100

100

100

0

0

0

100

100

100

97.3

90

82.1 (78.9 to 85.1)

   Trial registration date

100

100

100

100

100

100

100

100

100

0

0

0

78.5 (75.0 to 81.7)

   Secondary Ids

100

91

16

4

100

0

0

0

0

0

0

0

38.4 (34.5 to 42.4)

   Funding source(s)

100

100

96

76

66.7

69.7

90

100

100

100

100

27.8

83.1 (79.9 to 86.0)

   Primary sponsor

100

100

90

92

66.7

69.7

90.9

100

31.9

100

100

27.8

75.9 (72.3 to 79.2)

   Secondary sponsor(s)

14

10

38

0

0

6.1

6.1

0

0

0

0

0

7.7 (5.7 to 10.1)

   Responsible contact person

0

0

100

0

0

0

0

0

0

0

0

0

8.2 (6.1 to 10.7)

   Research contact person

95

20

100

98

93.9

63.6

30.3

0

0

0

0

60

54.1 (50.1 to 58.1)

   Title of the study (brief title)

98

18

66

0

0

60.6

0

0

0

0

0

12.2

29.5 (25.9 to 33.3)

   Official scientific title of the study

83

95

100

94

97

69.7

84.9

100

100

0

89.2

82.2

89.3 (86.6 to 91.7)

   Research ethics review

1

0

78

0

3

0

3

0

0

0

0

0

6.9 (5.0 to 9.2)

   Condition

70

85

92

66

97

100

84.9

100

95.8

100

83.8

22.2

75.2 (71.6 to 78.6)

   Intervention(s)

56

68

74

24

75.8

97

42.4

0

100

0

64.9

17.8

58.4 (54.3 to 62.3)

   Key inclusion and exclusion criteria

23

97

100

44

18.2

87.9

0

100

97.2

50

64.9

28.9

58.5 (54.5 to 62.5)

   Study type

43

74

98

58

9.1

97

33.3

0

94.4

0

64.9

45.6

61.3 (57.3 to 65.2)

   Anticipated trial start date

8

65

100

100

0

39.4

3

0

100

0

64.9

0

46.4 (42.4 to 50.4)

   Target sample size

40

83

100

24

72.7

100

39.4

0

80.6

0

64.9

0

55.2 (51.2 to 59.2)

   Recruitment status

3

99

100

100

93.9

100

12.1

100

0

0

54.1

7.8

50.0 (46.0 to 54.0)

   Primary outcome

7

48

100

34

0

100

18.2

0

83.3

0

64.9

2.2

40.5 (36.6 to 44.5)

   Key secondary outcomes

6

10

58

6

6.1

54.6

3

0

61.1

0

48.7

1.1

21.6 (18.4 to 25.1)

  1. Note: In CT, PDQ and STD 'Funding source(s)' and 'Primary sponsor' are not distinct. By default contact person without specification has been refereed to Research contact person.
  2. Abbreviation: ISRCTN, Current Controlled Trials; CT, ClinicalTrials.gov; ACTR, Australian Clinical Trials Registry; UK NRR, UK National Research Register; PDQ, US National Cancer Institute; STD, Stroke Trials Directory; RT, Rehabilitation Trials; R, Roche; GSK, GlaxoSmithKline; N, Novartis; CSR, ClinicalStudyResults.