Table 2.
General biostatistical quality of study proposals
| Item 6: Do you in general have the impression that the biostatistical quality of ethical proposals for studies regulated by AMG/MPG differs compared with proposals in a non-regulated setting? | n=47 (%) |
| Yes, ethical proposals for studies regulated by AMG/MPG have a higher biostatistical quality on average | 45 (91.8) |
| Yes, ethical proposals for studies in a non-regulated setting have a higher biostatistical quality on average | 0 (0.0) |
| No, the biostatistical quality does not differ on average | 2 (4.1) |
| Item 11: How do you consider the need for additional training in the following biostatistical areas for investigators submitting protocols to medical ethics committees? | n=45 (%) |
| Study design | |
| Low | 7 (15.6) |
| Middle | 23 (51.1) |
| High | 15 (33.3) |
| Wording of the study aims, hypotheses and/or endpoints | |
| Low | 1 (2.2) |
| Middle | 22 (48.9) |
| High | 22 (48.9) |
| Sample size calculation | |
| Low | 2 (4.4) |
| Middle | 15 (33.3) |
| High | 27 (60.00) |
| Not assessable | 1 (2.2) |
| Differentiation between confirmatory and exploratory analyses | |
| Low | 4 (8.9) |
| Middle | 17 (37.8) |
| High | 24 (53.3) |
| Handling of missing values | |
| Low | 2 (4.4) |
| Middle | 9 (20.00) |
| High | 34 (75.6) |
| Description of the statistical analysis | |
| Low | 1 (2.3) |
| Middle | 23 (52.3) |
| High | 20 (45.5) |
| Multiple comparisons problems | |
| Low | 3 (6.7) |
| Middle | 16 (35.6) |
| High | 26 (57.8) |
| Adjustment for covariables | |
| Low | 3 (6.7) |
| Middle | 18 (40.0) |
| High | 24 (53.3) |
| Randomisation/stratification | |
| Low | 10 (22.2) |
| Middle | 27 (60.00) |
| High | 6 (13.3) |
| Not assessable | 2 (4.4) |
| Additional aspects (added as free-text response by the participants) | |
| Data management | |
| Regulatory view | |
| Testing versus estimating | |
AMG/MPG, German Medicines Act/German Act on Medical Devices.