rejectprob function

Rejection Probability Calculation

Calculate the probability of rejecting the null hypothesis at the end of the second stage in the Single-to-double Arm Transition Design

rejectprob(pe,ps,n1,n2,r1,z)

Arguments

• pe: The response rate of the experimental arm.
• ps: The response rate of the standard arm.
• n1: The number of subjects in the experiemntal arm in the single-arm stage.
• n2: The number of subjects in each arm in the double-arm stage.
• r1: The minimum number of responses to achieve in the single-arm stage in order for the trial to proceed into the next stage.
• z: The threshold value for the Z test, i.e., the Z statistic should be greater than $z$ in order to reject the null hypothesis at the end of the second stage.

Returns

• n1: The number of subjects in the experiemntal arm in the single-arm stage.

• n2: The number of subjects in each arm in the double-arm stage.

• r1: The minimum number of responses to achieve in the single-arm stage in order for the trial to proceed into the next stage.The number of responses observed at the end of single-arm stage should be greater than or equal to $r1$ for the trial to proceed.

• ess0: The expected sample size under the null hypothesis.

• ess1: The expected sample size under the alternative hypothesis.

• asn: The average sample number taken as the average of $ess0$ and $ess1$.

References

Shi H., Yin G. (2017), START: Single-to-double Arm Transition Design for Phase II Clinical Trials.

Author(s)

Haolun Shi shl2003@connect.hku.hk,

Guosheng Yin gyin@hku.hk

Examples

rejectprob(pe=0.2,ps=0.4,n1=20,n2=40,r1=10,z=qnorm(0.9))