Calibrate the design parameters for the Single-to-double Arm Transition Design
findparameter(p0,p1,alpha1,beta1,alpha2,beta2)
Arguments
p0: The minimally required level for the response rate to be clinically meaningful.
p1: The desirable target rate.
alpha1: The type I error rate in the first stage.
beta1: The type II error rate in the first stage.
alpha2: The type I error rate in the second stage.
beta2: The type II error rate in the second stage.
Returns
n1: The number of subjects in the experimental 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. Submitted.