Table 4: Decision for a diagnostic clinical performance trial in the new region (sensitivity).

Δ

P new P

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

.

.