Table 4

Environment-driven criteria in the selection of phase II–III trial sites (phase III–IV for medical devices)

CriteriaMeanUpper 95% CLLower 95% CLSD
Size of market/eligible patients in a region23.825.222.413.3
Speed of MoH/ethics committees approval23.424.622.112.0
Disease management system/networks18.920.417.513.4
Cost of running trial15.216.314.29.8
Presence of country on ‘core country list’11.813.010.710.9
Government financial/tax incentives6.
  • 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.