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Table 4 Items of primary concern

From: Review of the registration of clinical trials in UMIN-CTR from 2 June 2005 to 1 June 2010 - focus on Japan domestic, academic clinical trials

Category

Number of trials

%

1. Malignancy/others

  

Malignancy

1,327

47.8

Others

1,452

52.2

2. Genomic information

  

Used

230

8.3

Not used

2,549

91.7

3. Confirmatory/exploratory

  

Confirmatory

1,010

36.3

Exploratory

762

27.4

Missing data

1,007

36.2

4. Explanatory/pragmatic

  

Explanatory

326

11.7

Pragmatic

1,081

38.9

Missing data

1,372

49.4

5. Basic design

  

Parallel

1,334

48.0

Crossover

135

4.9

Factorial

17

0.6

Single-arm

1,289

46.4

Expanded access

4

0.1

6. Randomization

  

Randomized

1,346

48.4

Non-randomized

1,433

51.6

7. Blinding

  

Open

2,181

78.5

Assessor blinded

298

10.7

Single-blind (participants)

87

3.1

Single-blind (investigators and assessors)

33

1.2

Double-blind

180

6.5

8. Control

  

Placebo

187

6.7

No treatment

249

9.0

Active

959

34.5

Dose comparison

70

2.5

Historical

281

10.1

Uncontrolled

1,033

37.2

9. Number of arms

  

1

1,289

46.4

2

1,282

46.1

3

145

5.2

>4

63

2.3

10. Type of intervention a

  

Medicine

2,074

74.6

Vaccine

112

4.0

Genetic

16

0.6

Food

75

2.7

Device, equipment

273

9.8

Behavior, custom

133

4.8

Maneuver

445

16.0

Others

0

0.0

11. Target sample size

  

1 to 10

210

7.6

11 to 100

1,781

64.1

101 to 1,000

725

26.1

1001 to 1,0000

58

2.1

>10,000

5

0.2

12. Trial period (months)b

  

0 to 6

138

5.0

7 to 12

180

6.5

13 to 36

1,057

38.0

37 to 60

611

22.0

>60

428

15.4

Missing data

365

13.1

13. Report of results c

  

Unpublished

2,501

90.0

Published

136

4.9

Partially published

142

5.1

14. Disclosure of trial before/after trial start d

  

Disclosure first

303

10.9

Trial start first

2,476

89.1

Total

2,779

100

  1. aValues within this category are not mutually exclusive (total number: >2,779); bperiod between trial start date and date of last patient’s final visit; c'published’: the final trial results were published regardless of the kind of publication form (journals, academic conferences, webpages, and so on), 'partially published’: only the results of interim analyses were published; ddate of first enrollment was taken as the trial start date.