Table 7.
Predictors of nonregistration of the published expanded access studies.
Variables | Univariate analysis | Multivariate analysis | |||
|
Odds ratio (95% CI)a | P value | Adjused odds ratio (95% CI)a | P value | |
Sample | 0.99 (0.99-0.99) | .009 | 0.99 (0.99-1.0) | .48 | |
Sponsor |
|
|
|
||
|
Industry | referent | N/Ab | N/A |
|
|
Nonindustry | 1.6 (1.14-2.23) | .008 | 1.55 (1.08-2.24) | .02 |
|
None | 1.63 (1.06-2.51) | .02 | 1.6 (1.0-2.55) | .05 |
Multicenter study |
|
|
|
|
|
|
Yes | referent | N/A | N/A | N/A |
|
No | 0.7 (0.56-0.87) | .002 | 1.02 (0.73-1.43) | .87 |
Multinational study |
|
|
|
|
|
|
Yes | referent | N/A | N/A | N/A |
|
No | 0.9 (0.7-0.1.14) | .40 | N/A | N/A |
aExcept for sample (which is a continuous variable), odds ratios and 95% CIs are shown related to the referent value for each of the remaining variables (sponsor, multicenter study, multinational study).
bN/A: not applicable.