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. 2024 Jun 24;43:100983. doi: 10.1016/j.lanepe.2024.100983

Table 4.

Linear regression analysis of factors associated with clinical development time length.

Variable Univariable P Multivariable P
Outbreak setting
 aEID Ref Ref
 Non-EID −4.7 (−6.8 to −2.6) <0.001 −5.4 (−8.2 to −2.6) <0.001
Pathogen(s) targeted
 Virus Ref Ref
 Bacteria 3.0 (0.8–5.2) 0.008 0.3 (−1.9 to 2.4) 0.82
 Other/mix/fungi 5.3 (0.1–10.7) 0.054 1.2 (−3.8 to 6.3) 0.48
Vaccine
 Yes Ref Ref
 No 1.5 (−0.7 to 3.7) 0.18 0.2 (−2.1 to 2.5) 0.86
Combination drug
 No Ref Ref
 Yes −2.7 (−5.2 to 0.3) 0.03 −2.7 (−4.9 to −0.4) 0.02
bCMA status
 No Ref Ref
 Yes −3.1 (−6.1 to −0.1) 0.046 −1.0 (−4.4 to 2.3) 0.53
Orphan drug
 No Ref Ref
 Yes 3.9 (0.4–7.4) 0.02 3.1 (−0.6 to 6.8) 0.10
Accelerated assessment
 No Ref Ref
 Yes −3.5 (−7.5 to 0.5) 0.08 −4.0 (−7.6 to −0.5) 0.03
Type of sponsor-investigator of phase 1 trial
 Pharmaceutical Ref Ref
 Academic −4.9 (−11.8 to 1.9) 0.16 −0.8 (−6.7 to 5.1) 0.79
 Governmental 0.6 (−3.5 to 4.7) 0.76 2.5 (−1.3 to 6.2) 0.19

P-values below 0.05 were considered statistically significant (bold).

a

EID: emerging infectious disease.

b

CMA: conditional marketing authorisation. CI: 95% confidence interval; Ref, reference category.