Table 2 Results of questionnaire survey
Questionnaire | Parameter | Funding source * | p-value†| ||||
|---|---|---|---|---|---|---|---|
| Â | Â | Public N = 14 | Private N = 29 | Combined N = 9 | Others N = 11 | Total N = 63 | Â |
Number of participants | N | 12 | 29 | 9 | 11 | 61 | 0.6296 |
| Â | Mean | 1260.6 | 3301.9 | 3361.1 | 1489.4 | 2582.2 | Â |
| Â | SD | 991.9 | 4311.4 | 6295.9 | 1202.5 | 3910.3 | Â |
| Â | Minimum | 861.5 | 1748 | 1200 | 1090 | 1200 | Â |
| Â | Q1 | 575 | 500 | 800 | 500 | 500 | Â |
| Â | Median | 2000 | 4418 | 2000 | 2046.5 | 3000 | Â |
| Â | Q3 | 300 | 110 | 300 | 300 | 110 | Â |
| Â | Maximum | 3000 | 20000 | 20000 | 4000 | 20000 | Â |
Total investigation cost | JPY < 10 million(USD < 0.11 million) | 0 | 2 (6.9%) | 0 | 6 (54.5%) | 8 (12.7%) | 0.0003 |
| Â | 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%) | Â |
| Â | 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%) | Â |
| Â | 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%) | Â |
| Â | JPY 300 million - 1 billion (USD 3.27 - 10.9 million) | 0 | 4 (13.8%) | 6 (54.5%) | 0 | 10 (15.9%) | Â |
| Â | JPY 1 - 3 billion (USD 10.9 - 32.7 million) | 0 | 2 (6.9%) | 0 | 0 | 2 (3.2%) | Â |
|  | JPY ≥ 3 billion (USD ≥ 32.7 million) | 0 | 1 (3.4%) | 0 | 0 | 1 (1.6%) |  |
| Â | Unknown or unspecified | 1 (7.1%) | 6 (20.7%) | 0 | 1 (9.1%) | 8 (12.7%) | Â |
Organization responsible for monitoring‡ | Pharmaceutical company | 0 | 6 (20.7%) | 1 (11.1%) | 1 (9.1%) | 8 (12.7%) | - |
| Â | CRO (Contract research organization) | 0 | 5 (17.2%) | 2 (22.2%) | 0 | 7 (11.1%) | Â |
| Â | Academic organization | 5 (35.7%) | 9 (31.0%) | 3 (33.3%) | 9 (81.8%) | 26 (41.3%) | Â |
| Â | Others | 10 (71.4%) | 13 (44.8%) | 6 (54.5%) | 2 (18.2%) | 31 (49.3%) | Â |
Organization responsible for data management‡ | Pharmaceutical company | 0 | 6 (20.7%) | 1 (11.1%) | 0 | 7 (11.1%) | - |
| Â | CRO (Contract research organization) | 1 (7.1%) | 8 (27.6%) | 0 | 0 | 9 (14.3%) | Â |
| Â | Academic organization | 5 (35.7%) | 9 (31.0%) | 4 (44.4%) | 8 (72.7%) | 26 (41.3%) | Â |
| Â | Others | 10 (71.4%) | 10 (34.5%) | 6 (54.5%) | 2 (18.2%) | 28 (44.4%) | Â |
External efficacy evaluation committee | Yes | 9 (64.3%) | 17 (58.6%) | 8 (88.9%) | 6 (54.5%) | 40 (63.5%) | 0.5323 |
| Â | No | 5 (35.7%) | 7 (24.1%) | 1 (11.1%) | 4 (36.4%) | 17 (27.0%) | Â |
| Â | Unknown or unspecified | 0 | 5 (17.2%) | 0 | 1 (9.1%) | 6 (9.5%) | Â |
External safety monitoring committee | Yes | 11 (78.6%) | 16 (55.2%) | 7 (77.8%) | 6 (54.5%) | 40 (63.5%) | 0.6671 |
| Â | No | 3 (21.4%) | 9 (31.0%) | 2 (22.2%) | 4 (36.4%) | 18 (28.6%) | Â |
| Â | Unknown or unspecified | 0 | 4 (13.8%) | 0 | 1 (9.1%) | 5 (7.9%) | Â |
Biostatistician | Yes | 11 (78.6%) | 21 (72.4%) | 7 (77.8%) | 6 (54.5%) | 45 (71.4%) | 0.7010 |
| Â | No | 3 (21.4%) | 6 (20.7%) | 2 (22.2%) | 4 (36.4%) | 15 (23.8%) | Â |
| Â | Unknown or unspecified | 0 | 2 (6.9%) | 0 | 1 (9.1%) | 3 (4.8%) | Â |
Approval of IRB | Yes | 14 (100%) | 26 (89.7%) | 9 (100%) | 9 (81.8%) | 58 (92.1%) | 0.4785 |
| Â | No | 0 | 3 (10.9%) | 0 | 1 (9.1%) | 4 (6.3%) | Â |
| Â | Unknown or unspecified | 0 | 0 | 0 | 1 (9.1%) | 1 (1.6%) | Â |
Site of registration‡ | University hospital Medical Information Network (UMIN) | 7 (50.0%) | 8 (27.6%) | 5 (55.6%) | 4 (36.4%) | 24 (38.1%) | - |
| Â | clinicaltrials.gov | 7 (50.0%) | 7 (24.1%) | 4 (44.4%) | 3 (27.3%) | 21 (33.3%) | Â |
| Â | Japan Pharmaceutical Information Center (JAPIC) | 0 | 1 (3.4%) | 0 | 0 | 1 (1.6%) | Â |
| Â | Japan Medical Association | 0 | 0 | 0 | 0 | 0 | Â |
| Â | Others | 1 (7.1%) | 2 (6.9%) | 0 | 0 | 3 (4.8%) | Â |
| Â | Not registered | 3 (21.4%) | 13 (44.8%) | 3 (33.3%) | 4 (36.4%) | 23 (36.5%) | Â |
| Â | Unknown or unspecified | 1 (7.1%) | 0 | 0 | 1 (9.1%) | 2 (3.2%) | Â |