| Type: | Package |
| Title: | Single to Double Arm Transition Design for Phase II Clinical Trials |
| Version: | 1.0 |
| Date: | 2017-08-21 |
| Author: | Haolun Shi and Guosheng Yin |
| Maintainer: | Haolun Shi <shl2003@connect.hku.hk> |
| Description: | The package is used for calibrating the design parameters for single-to-double arm transition design proposed by Shi and Yin (2017). The calibration is performed via numerical enumeration to find the optimal design that satisfies the constraints on the type I and II error rates. |
| License: | GPL-2 | GPL-3 [expanded from: GPL (≥ 2)] |
| Imports: | Rcpp (≥ 0.12.7) |
| LinkingTo: | Rcpp |
| NeedsCompilation: | yes |
| Packaged: | 2017-08-22 02:16:17 UTC; ra3 |
| Repository: | CRAN |
| Date/Publication: | 2017-08-22 07:09:44 UTC |
Parameter Calibration
Description
Calibrate the design parameters for the Single-to-double Arm Transition Design
Usage
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. |
Value
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 |
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 |
Author(s)
Haolun Shi <shl2003@connect.hku.hk>,
Guosheng Yin <gyin@hku.hk>
References
Shi H., Yin G. (2017), START: Single-to-double Arm Transition Design for Phase II Clinical Trials. Submitted.
Examples
findparameter(p0=0.2,p1=0.5,alpha1=0.25,beta1=0.05,alpha2=0.2,beta2=0.25)
Rejection Probability Calculation
Description
Calculate the probability of rejecting the null hypothesis at the end of the second stage in the Single-to-double Arm Transition Design
Usage
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 |
Value
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 |
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 |
Author(s)
Haolun Shi <shl2003@connect.hku.hk>,
Guosheng Yin <gyin@hku.hk>
References
Shi H., Yin G. (2017), START: Single-to-double Arm Transition Design for Phase II Clinical Trials.
Examples
rejectprob(pe=0.2,ps=0.4,n1=20,n2=40,r1=10,z=qnorm(0.9))