Table 8 Tendendy in characteristics of 976 protocols according to clusters defined by a hierarchical analysis
CLUSTER I | CLUSTER II | CLUSTER III | CLUSTER IV | ||
|---|---|---|---|---|---|
N | 280 | 144 | 209 | 343 | |
Main characteristics | -drug testing -phase II -pharmaceutical sponsor -with direct benefit -phase IV | -phase I -without direct benefit -investigator: other -single centre -less than 2 months | -international scope -phase III -more than 200 patients -drug testing -with direct benefit | -not drugs -public setting -descriptive design -public sponsor -industrial sponsor | |
PER PROTOCOL | ANOVA p-value | ||||
Mean number of revisions | 0.94 | 1.05 | 1.08 | 0.98 | 0.70 |
Mean number of amendments | 0.78 | 0.46 | 2.14 | 0.53 | <0.0001 |
Estimated average time (initial evalution, revision, amendment) | 22.5 | 21.4 | 31.7 | 21.3 | <0.0001 |