Table 3. Mean scores for priorities for changes in the European Clinical Trials Directive.
| Type of change required post-implementation of the European Clinical Trials Directive | Mean rating | s.e. |
|---|---|---|
| Reduction in administrative burden | 1.20a | 0.16 |
| Harmonization of documents required for approval | 1.35ab | 0.22 |
| Increased public funding for prospective clinical trials | 1.42abc | 0.18 |
| More readily available support from the EU for translational clinical research | 1.50abc | 0.19 |
| Provision of ethical and regulatory approval free of charge for academic institutions | 1.53bc | 0.20 |
| Centralization of documents required for approval | 1.55bcd | 0.17 |
| National government or EU subsidization of insurance costs | 1.60bcde | 0.21 |
| Permitting co-sponsorship of academic prospective clinical trials | 1.60bcdef | 0.20 |
| Improved definition of interventional versus non-interventional clinical trial | 1.67bcdefg | 0.21 |
| Clearer differentiation between ‘commercial' and non-commercial clinical trial | 1.72bcdefgh | 0.22 |
| Improved definition of substantial versus non-substantial protocol amendment | 1.73cdefghij | 0,.22 |
| Reduction in the degree of monitoring required for investigator-led trials | 1.75cdefghijk | 0.23 |
| Implementation of a true single opinion in a member state | 1.82cdefghijkl | 0.24 |
| Improved definition of an interventional medicinal product (IMP) | 1.85cdefghijkl | 0.24 |
| EU or nationally funded local training on administrative requirements of the directive | 1.88cdefghiklm | 0.24 |
| Creation of a single Competent Authority for all EU member states | 1.90cdefghiklm | 0.24 |
| Permitting industry to use data from ‘non-commercial' clinical trials | 2.35m | 0.30 |
Participants were asked to rate the extent to which they agreed or disagreed that changes associated with the implementation of the European Clinical trials directive should be prioritized. A lower average score indicates greater average respondent agreement that the change should be prioritized. Superscript characters are used to indicate which means are significantly different from each other (as assessed by Tukey's post-hoc test for pairwise differences). Two means share a superscript character implies that they are not significantly different from each other. Otherwise they are.