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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%).