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. 2021 Oct 28;23(10):e26890. doi: 10.2196/26890

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.