Table 2: Decision for a method comparison trial in the new region (Xc = 150 cells/μL × 103).
Δ |
ρ |
Decision New Region |
Proportion of Subjects for Bridging Study |
Sample Size for Bridging Study |
|
1 |
1.000 |
0.92 |
No Clinical Trial |
. |
. |
2 |
0.999 |
0.85 |
No Clinical Trial |
. |
. |
3 |
0.996 |
0.77 |
No Clinical Trial |
. |
. |
4 |
0.984 |
0.70 |
No Clinical Trial |
. |
. |
5 |
0.955 |
0.62 |
No Clinical Trial |
. |
. |
6 |
0.894 |
0.54 |
Bridging Study |
0.09 |
18 |
7 |
0.783 |
0.47 |
New Clinical Trial |
. |
. |
8 |
0.637 |
0.39 |
New Clinical Trial |
. |
. |
9 |
0.460 |
0.32 |
New Clinical Trial |
. |
. |
10 |
0.292 |
0.24 |
New Clinical Trial |
. |
. |
11 |
0.159 |
0.16 |
New Clinical Trial |
. |
. |
12 |
0.074 |
0.09 |
New Clinical Trial |
. |
. |