Table 3 Results of multivariable logistic regression models predicting the likelihood of receiving each expedited designation: Priority Review, Fast Track, Breakthrough Therapy, and Accelerated Approval. Separate models were fitted for each designation, with common predictors including infectious disease indication, orphan drug status, surrogate endpoint usage, trial phase, and approval year. Odds ratios (ORs) and 95% confidence intervals (CI) are reported. Significant associations (p < 0.05) are noted.

From: Regulatory alignment in FDA expedited pathways for infectious diseases: a decadal review with predictive modeling insights

Predictor

Priority review OR (95% CI)

Fast track OR (95% CI)

Breakthrough therapy OR (95% CI)

Accelerated approval OR (95% CI)

Infectious disease

12.1 (5.4–27.3)***

5.4 (2.8–9.6)***

….

0.14 (0.03–0.66)*

Orphan drug designation

3.7 (2.1–6.5)***

….

2.2 (1.3–3.7)**

….

Trial phase

….

2.3 (1.4–3.8)**

….

….

Enrollment size

….

….

….

….

Approval year

….

….

….

….

  1. Dots (…..) indicate that the variable was included but did not yield a statistically significant result in the final model.
  2. *p < 0.05, **p < 0.01, ***p < 0.001.
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