Table 3.
Predictors of the absence of study detailed description in the records of expanded access studies registered with ClinicalTrials.gov.
| Variables | Univariate analysis | Multivariate analysis | |||
|
|
Odds ratio (95% CI)a | P value | Adjusted odds ratio (95% CI)a | P value | |
| First posted date |
|
|
|
|
|
|
|
2020 | referent | N/Ab | referent | N/A |
|
|
2019 | 1.02 (0.84-1.23) | .84 | N/A | N/A |
|
|
2018 | 1.12 (0.93-1.36) | .22 | N/A | N/A |
|
|
2017 | 1.0 (0.81-1.23) | .98 | N/A | N/A |
| Sponsor |
|
|
|
|
|
|
|
Industry | referent | N/A | referent | N/A |
|
|
Nonindustry | 0.76 (0.63-0.91) | .003 | 0.46 (0.19-1.08) | .07 |
| Multicenter study |
|
|
|
||
|
|
No | referent | N/A | referent | N/A |
|
|
Yes | 1.08 (0.63-0.91) | .41 | N/A | N/A |
| Multinational study |
|
|
|
|
|
|
|
No | referent | N/A | referent | N/A |
|
|
Yes | 0.93 (0.89-1.31) | .57 | N/A | N/A |
| US involvement |
|
|
|
|
|
|
|
No | referent | N/A | referent | N/A |
|
|
Yes | 0.95 (0.71-1.21) | .66 | N/A | N/A |
| Type of expanded access |
|
|
|
|
|
|
|
IPc | referent | N/A | referent | N/A |
|
|
ISd | 0.92 (0.75-1.2) | .33 | 0.75 (0.36-1.55) | .42 |
|
|
Tr. IND/Pr.e | 0.82 (0.77-1.09) | .02 | 0.47 (0.23-0.96) | .03 |
aFor each variable (first posted date; sponsor; multicenter study; multinational study; US involvement; type of expanded access), odds ratios and 95% CI are shown related to the referent value.
bN/A: not applicable.
cIP: individual patients.
dIS: intermediate-size population.
eTr. IND/Pr.: Treatment IND/protocol.