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Table 5 50% change of selection bias effect and linear time trend effect (η,θ) on probability of type I error for complete randomization (CR) and big stick design (BSD)

From: ERDO - a framework to select an appropriate randomization procedure for clinical trials

Randomization

Selection

Linear-Time

Type I Error

P RP (ω≤0.05)

Procedure

Bias

Trend Bias

Probability

 

[R P]

η

θ

[mean]

 

CR

0.04

0.13

0.050

0.52

CR

0.09

0.26

0.050

0.53

CR

0.14

0.39

0.051

0.56

BSD(3)

0.04

0.13

0.051

0.10

BSD(3)

0.09

0.26

0.054

0.11

BSD(3)

0.14

0.39

0.059

0.10

BSD(4)

0.04

0.13

0.050

0.32

BSD(4)

0.09

0.26

0.052

0.34

BSD(4)

0.14

0.39

0.053

0.34

BSD(5)

0.04

0.13

0.050

0.45

BSD(5)

0.09

0.26

0.051

0.46

BSD(5)

0.14

0.39

0.051

0.47

BSD(10)

0.04

0.13

0.050

0.52

BSD(10)

0.09

0.26

0.050

0.53

BSD(10)

0.14

0.39

0.050

0.57