Table 1. Number of new chemical entities approved by the FDA 2010–2014 and average years in clinical trials when the first clinical trials were performed before the target technology was established (before Te) or after the technology was established (after Te).
| Type | all | before Te | after Te | all | before Te | after Te | p |
|---|---|---|---|---|---|---|---|
| # of compounds (2010–2014) | # years in clinical trials (average) | ||||||
| All* | 102 | 29 | 73 | 9.4 | 11.5 | 8.5 | 0.0003 |
| Pheontypic | 15 | 5 | 10 | 10.7 | 13.0 | 9.5 | 0.2NS |
| First-in-class | 53 | 18 | 35 | 9.8* | 9.5 | 8.7 | 0.003 |
| Follow-on | 49 | 12 | 37 | 8.9* | 11 | 8.3 | 0.01 |
| Targeted (NCE)+Biologic | 87 | 24 | 63 | 9.4 | 11.5 | 8.5 | 0.00004 |
| Targeted (NCE) | 54 | 13 | 41 | 8.4 | 10.2 | 7.8 | 0.01 |
| Biologic | 33 | 11 | 22 | 10.2 | 12.4 | 9.3 | 0.003 |
Data are shown for 102 of 138 compounds approved by the FDA between 2010 and 2014. Of the remaining compounds, 17 are phenotypic compounds with an uncertain target/mechanism of action, and 19 exhibited a growth pattern that did not fit the exponentiated logistic model. p values from t-test.
*clinical timelines for first in class drugs compared to follow-on were not significantly different (t-test, p-value = 0.23)
NS = not significant