Table 4: Decision for a diagnostic clinical performance trial in the new region (sensitivity).
Δ |
ρ |
Decision New Region |
Proportion of Subjects for Bridging Study |
Sample Size for Bridging Study |
|
0 |
1.00 |
1.00 |
No Clinical Trial |
. |
. |
0.01 |
0.95 |
0.89 |
No Clinical Trial |
. |
. |
0.02 |
0.86 |
0.78 |
Bridging Study |
0.50 |
78 |
0.03 |
0.72 |
0.67 |
Bridging Study |
0.31 |
|
0.04 |
0.56 |
0.56 |
Bridging Study |
0.20 |
|
0.05 |
0.38 |
0.44 |
New Clinical Trial |
. |
. |
0.06 |
0.24 |
0.33 |
New Clinical Trial |
. |
. |
0.07 |
0.13 |
0.22 |
New Clinical Trial |
. |
. |
0.08 |
0.06 |
0.11 |
New Clinical Trial |
. |
. |