Environment-driven criteria in the selection of phase II–III trial sites (phase III–IV for medical devices)
| Criteria | Mean | Upper 95% CL | Lower 95% CL | SD |
|---|---|---|---|---|
| Size of market/eligible patients in a region | 23.8 | 25.2 | 22.4 | 13.3 |
| Speed of MoH/ethics committees approval | 23.4 | 24.6 | 22.1 | 12.0 |
| Disease management system/networks | 18.9 | 20.4 | 17.5 | 13.4 |
| Cost of running trial | 15.2 | 16.3 | 14.2 | 9.8 |
| Presence of country on ‘core country list’ | 11.8 | 13.0 | 10.7 | 10.9 |
| Government financial/tax incentives | 6.9 | 7.6 | 6.2 | 6.6 |
Respondents (N=341) were asked to divide 100 points across the above six criteria when selecting trial sites for phase III/IV (3/4) studies: Pharma, Biotech, CROs and CTUs answered for phase III (3) studies. Medical device and all others answered for phase IV (4) studies. There was evidence of a statistically significant difference in the level of importance of the six criteria (p<0.0001).
CL, confidence limit; CROs, clinical research organisations; CTUs, clinical trial units; MoH, Ministry of Health.