Table 5 Adaptations planned at the time of scientific advice (SA) letter versus the adaptations implemented in the protocol after SA. A given trial can include several and possibly different types of adaptive elements
Adaptations | Planned at the time of SA opinion letter | Implemented | Not implemented | No adaptations mentioned | Not retrieved |
|---|---|---|---|---|---|
Dose selection (phase II/III) | 16 | 6 | 0 | 2 | 8 |
Sample size reassessment | 43 | 6 | 4 | 9 | 24 |
Stopping for futility | 31 | 7 | 2 | 8 | 14 |
Stopping for early efficacy | 19 | 1 | 2 | 5 | 11 |