TABLE 3.
Predicted reductions in trial duration (months) and size with digital endpoints by therapeutic area.
| Phase II Duration | Phase III Duration | Phase II Enrollment | Phase III Enrollment | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Predicted value | Absolute decline | Percent decline | Predicted value | Absolute decline | Percent decline | Predicted value | Absolute decline | Percent decline | Predicted value | Absolute decline | Percent decline | |
| Cardiovascular | ||||||||||||
| Non‐digital | 14.8 | 21.9 | 93.0 | 181.2 | ||||||||
| Digital | 11.2 | 3.5 | 24.0 | 17.0 | 4.9 | 22.0 | 77.7 | 15.2 | 16.4 | 160.0 | 21.2 | 11.7 |
| CNS | ||||||||||||
| Non‐digital | 17.4 | 23.9 | 109.3 | 277.0 | ||||||||
| Digital | 13.3 | 4.2 | 24.0 | 18.7 | 5.2 | 22.0 | 94.1 | 15.2 | 13.9 | 244.6 | 32.4 | 11.7 |
| Diabetes | ||||||||||||
| Non‐digital | 13.7 | 18.2 | 130.8 | 312.6 | ||||||||
| Digital | 10.4 | 3.3 | 24.0 | 14.2 | 4.0 | 22.0 | 115.6 | 15.2 | 11.6 | 276.0 | 35.6 | 11.7 |
Note: Predicted values for dependent variables determined at mean values for the continuous explanatory variables. Phase duration = (primary completion date − study start date), with dates as defined in ClinicalTrials.gov.