Table 3 The data extracted split by the adaptive method applied
Data extracted | Adaptive method applied | |||||
|---|---|---|---|---|---|---|
Group sequential methods (n = 50) | Dose modifications (n = 8) | Sample size re-estimation (n = 4) | Adaptive randomisation (n = 1) | Change in primary endpoint (n = 1) | Change in patient eligibility (n = 1) | |
Trial phase | ||||||
II | 13 | 2 | 0 | 1 | 0 | 0 |
II/III | 2 | 1 | 1 | 0 | 0 | 0 |
III | 35 | 5 | 3 | 0 | 1 | 1 |
Number of arms | ||||||
2 | 42 | 7 | 2 | 1 | 1 | 1 |
3 | 6 | 1 | 0 | 0 | 0 | 0 |
4 | 1 | 0 | 1 | 0 | 0 | 0 |
5 | 1 | 0 | 1 | 0 | 0 | 0 |
Stage of reporting | ||||||
Interim analysis | 33 | 2 | 2 | 0 | 1 | 1 |
Subgroup analysis | 0 | 1 | 0 | 0 | 0 | 0 |
Final analysis | 17 | 5 | 2 | 1 | 0 | 0 |
Planning of adaptive design method | ||||||
Pre-determined | 45 | 8 | 1 | 1 | 0 | 1 |
Ad-hoc | 1 | 0 | 0 | 0 | 0 | 0 |
Both | 4 | 0 | 3 | 0 | 1 | 0 |
Explicitly stated Adaptive design | ||||||
Yes | 1 | 1 | 1 | 1 | 0 | 0 |
No | 49 | 7 | 3 | 0 | 1 | 1 |
Planned stopping criteria | ||||||
Yes | 50 | 5 | 4 | 0 | 1 | 1 |
No | 0 | 3 | 0 | 1 | 0 | 0 |
Trial stopped early | ||||||
Yes | 26 | 1 | 4 | 0 | 1 | 0 |
No | 24 | 7 | 0 | 1 | 0 | 1 |