Table 3 Summary of the clinical trial design characteristics
Traditional group sequential design (n = 43) | Adaptive design (n = 13) | |||
|---|---|---|---|---|
No. | Percentages | No. | Percentages | |
Sample size | ||||
< 200 | 4 | 9.3% | 2 | 15.4% |
200–499 | 0 | 0 | 2 | 15.4% |
500–999 | 5 | 11.6% | 4 | 30.8% |
1,000–4,900 | 14 | 32.6% | 1 | 7.7% |
5,000–9,999 | 9 | 20.9% | 2 | 15.4% |
> 10,000 | 11 | 25.6% | 2 | 15.4% |
Trial type | ||||
Phase II | 1 | 2.3% | 4 | 30.8% |
Phase III (or IIIb) | 20 | 46.5% | 8 | 61.5% |
Not available | 22 | 51.2% | 1 | 7.7% |
Study type* | ||||
Efficacy | 33 | 76.7% | 7 | 53.8% |
Safety | 6 | 14% | 0 | 0 |
Both | 4 | 9.3% | 6 | 46.2% |
Trial arms | ||||
2 | 37 | 86% | 8 | 61.5% |
3 | 4 | 9.3% | 3 | 23.1% |
>=4 | 2 | 4.7% | 2 | 15.4% |
Intervention | ||||
Drug | 34 | 79.1% | 8 | 61.5% |
Surgery | 8 | 18.6% | 1 | 7.7% |
Biomarker | 0 | 0 | 1 | 7.7% |
Device | 1 | 2.3% | 3 | 23.1% |
Follow-up (mean/median) (years) | ||||
< 2 | 19 | 44.2% | 10 | 76.9% |
>=2 | 24 | 55.8% | 3 | 23.1% |