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Table 2 Results of questionnaire survey

From: Funding and infrastructure among large-scale clinical trials examining cardiovascular diseases in Japan: evidence from a questionnaire survey

Questionnaire

Parameter

Funding source *

p-value

  

Public

N = 14

Private

N = 29

Combined

N = 9

Others

N = 11

Total

N = 63

 

Number of participants

N

12

29

9

11

61

0.6296

 

Mean

1260.6

3301.9

3361.1

1489.4

2582.2

 
 

SD

991.9

4311.4

6295.9

1202.5

3910.3

 
 

Minimum

861.5

1748

1200

1090

1200

 
 

Q1

575

500

800

500

500

 
 

Median

2000

4418

2000

2046.5

3000

 
 

Q3

300

110

300

300

110

 
 

Maximum

3000

20000

20000

4000

20000

 

Total investigation cost

JPY < 10 million(USD < 0.11 million)

0

2 (6.9%)

0

6 (54.5%)

8 (12.7%)

0.0003

 

JPY 10 - 30 million (USD 0.11 - 0.33 million)

2 (14.3%)

1 (3.4%)

1 (11.1%)

1 (9.1%)

5 (7.9%)

 
 

JPY 30 - 100 million (USD 0.33 - 1.09 million)

4 (28.6%)

3 (10.3%)

1 (11.1%)

2 (18.2%)

10 (15.9%)

 
 

JPY 100 - 300 million (USD 1.09 - 3.27 million)

7 (50.0%)

10 (34.5%)

1 (11.1%)

1 (9.1%)

19 (30.2%)

 
 

JPY 300 million - 1 billion (USD 3.27 - 10.9 million)

0

4 (13.8%)

6 (54.5%)

0

10 (15.9%)

 
 

JPY 1 - 3 billion (USD 10.9 - 32.7 million)

0

2 (6.9%)

0

0

2 (3.2%)

 
 

JPY ≥ 3 billion (USD ≥ 32.7 million)

0

1 (3.4%)

0

0

1 (1.6%)

 
 

Unknown or unspecified

1 (7.1%)

6 (20.7%)

0

1 (9.1%)

8 (12.7%)

 

Organization responsible for monitoring

Pharmaceutical company

0

6 (20.7%)

1 (11.1%)

1 (9.1%)

8 (12.7%)

-

 

CRO (Contract research organization)

0

5 (17.2%)

2 (22.2%)

0

7 (11.1%)

 
 

Academic organization

5 (35.7%)

9 (31.0%)

3 (33.3%)

9 (81.8%)

26 (41.3%)

 
 

Others

10 (71.4%)

13 (44.8%)

6 (54.5%)

2 (18.2%)

31 (49.3%)

 

Organization responsible for data management

Pharmaceutical company

0

6 (20.7%)

1 (11.1%)

0

7 (11.1%)

-

 

CRO (Contract research organization)

1 (7.1%)

8 (27.6%)

0

0

9 (14.3%)

 
 

Academic organization

5 (35.7%)

9 (31.0%)

4 (44.4%)

8 (72.7%)

26 (41.3%)

 
 

Others

10 (71.4%)

10 (34.5%)

6 (54.5%)

2 (18.2%)

28 (44.4%)

 

External efficacy evaluation committee

Yes

9 (64.3%)

17 (58.6%)

8 (88.9%)

6 (54.5%)

40 (63.5%)

0.5323

 

No

5 (35.7%)

7 (24.1%)

1 (11.1%)

4 (36.4%)

17 (27.0%)

 
 

Unknown or unspecified

0

5 (17.2%)

0

1 (9.1%)

6 (9.5%)

 

External safety monitoring committee

Yes

11 (78.6%)

16 (55.2%)

7 (77.8%)

6 (54.5%)

40 (63.5%)

0.6671

 

No

3 (21.4%)

9 (31.0%)

2 (22.2%)

4 (36.4%)

18 (28.6%)

 
 

Unknown or unspecified

0

4 (13.8%)

0

1 (9.1%)

5 (7.9%)

 

Biostatistician

Yes

11 (78.6%)

21 (72.4%)

7 (77.8%)

6 (54.5%)

45 (71.4%)

0.7010

 

No

3 (21.4%)

6 (20.7%)

2 (22.2%)

4 (36.4%)

15 (23.8%)

 
 

Unknown or unspecified

0

2 (6.9%)

0

1 (9.1%)

3 (4.8%)

 

Approval of IRB

Yes

14 (100%)

26 (89.7%)

9 (100%)

9 (81.8%)

58 (92.1%)

0.4785

 

No

0

3 (10.9%)

0

1 (9.1%)

4 (6.3%)

 
 

Unknown or unspecified

0

0

0

1 (9.1%)

1 (1.6%)

 

Site of registration

University hospital Medical Information Network (UMIN)

7 (50.0%)

8 (27.6%)

5 (55.6%)

4 (36.4%)

24 (38.1%)

-

 

clinicaltrials.gov

7 (50.0%)

7 (24.1%)

4 (44.4%)

3 (27.3%)

21 (33.3%)

 
 

Japan Pharmaceutical Information Center (JAPIC)

0

1 (3.4%)

0

0

1 (1.6%)

 
 

Japan Medical Association

0

0

0

0

0

 
 

Others

1 (7.1%)

2 (6.9%)

0

0

3 (4.8%)

 
 

Not registered

3 (21.4%)

13 (44.8%)

3 (33.3%)

4 (36.4%)

23 (36.5%)

 
 

Unknown or unspecified

1 (7.1%)

0

0

1 (9.1%)

2 (3.2%)

 
  1. * Funding sources were categorized based on the answers to questionnaire regarding funding sources;
  2. - Public: Public agency
  3. - Private: Foundation, private organization
  4. - Combined: More than one funding source
  5. - Others: Self-funding, other
  6. P-values were calculated using Kruskal-Wallis test.
  7. Multiple answers were allowed. Therefore, the sum of all frequencies is not equal to 63 (100%).