| one_design {PlatformDesign} | R Documentation |
Calculate other design parameters of a two-period K+M-experimental arm platform design given sample sizes
Description
Provide other design parameters for a two-period K+M-experimental arm trial, given n2 and n0_2, nt, K, M, fwer(or pwer) and marginal power (of the K-experimental arm trial). This function serves for the purpose of spot-testing for any pre-specified n, n0_2 pair. Please use platform_design() for finding optimal values of n and n0_2, controlling for FWER (or PWER).
Usage
one_design(
n2,
n0_2,
nt,
K,
M,
fwer = NULL,
pwer = NULL,
marginal.power,
delta,
seed = 123
)
Arguments
n2 |
a positive integer, which is the sample size in each experimental arm in the K+M-experimental arm trial |
n0_2 |
a positive integer, which is the sample size of the concurrent control for each experimental arms in the K+M-experimental arm trial |
nt |
a positive integer, the number of patients already enrolled on each of the K initial experimental arms when the M new arms are added |
K |
a positive integer, the number of experimental arms in the first period in a two-period K+M-experimental arm trial |
M |
a positive integer, the number of delayed (newly added) experimental arms added in the beginning of the second period of the K+M-experimental arm trial |
fwer |
the family-wise error rate (FWER) to be controlled, default to be the same throughout the trial |
pwer |
the pair-wise error rate (PWER) to be controlled, default to be the same throughout the trial |
marginal.power |
the marginal power to achieve in the K-experimental arm (and K+M-experimental arm) trial |
delta |
the standardized clinical effect size expected to be detected in the trial |
seed |
an integer for random number generation for numerically evaluating integration, default = 123 |
Details
Given n2 and n0_2, nt, K, M, fwer (or pwer) and marginal power (of the K-experimental arm trial), provide other design parameters for a two-period K+M-experimental arm trial.
Value
design_Karm contains the design parameters for the K-experimental arm trial including:
K, the number of experimental arms in the K-experimental arm trial
n1, the sample size for each of the K experimental
arms in the k-experimental arm trial
n0_1, the sample size of the common control arm in the K-experimental arm trial
N1 the total sample size of a K-experimental arm trial
z_alpha1, the critical value for the comparison between any of the K
experimental arms and the control in the K-experimental arm trial
FWER1, the family-wise error rate for the K-experimental arm trial
z_beta1, the quantile of the marginal power, i.e., qnorm(marginal
power) for the K-experimental arm trial
Power1, the disjunctive power for the K-experimental arm trial
cor0, the correlation of Z-test statistics between any two of the K
experimental arms
delta, the standardized effect size expected to be detected in the
trial
designs contains the recommended optimal design parameters for the K+M-experimental arm trial including:
n2 and n0_2, the sample sizes of each of the K+M-experimental arm
experimental arms and its corresponding concurrent control, respectively, in the K+M-experimental arm trial
nt and n0t, the number of patients already enrolled on each
of the K initial experimental arms and the common control arm, respectively, at the time the
M new arms are added
nc, the total sample size of the control arm for the K+M-experimental arm trial, i.e.
, the sum of concurrent (n0_2) and nonconcurrent (n0t) controls
N2, the total sample size of the two-period K+M-experimental arm trial
A1, the allocation ratio (control to experimental arm) before the M
new experimental arms are added and after the initial K experimental arms end
A2, the allocation ratio after the M new experimental arms are
added and before the initial K experimental arms end
cor1, the correlation of Z-test statistics between any two of the K
initially opened experimental arms (or between any two of the M newly added arms)
cor2, the correlation of Z-test statistics between any pair of one
initially opened and one newly added experimental arm
critical_value2, the critical value for the comparison between each
experimental arms and the corresponding control in the K+M-experimental arm trial
mariginal.power2, the marginal power for the K+M-experimental arm trial
disjunctive.power2, the disjunctive power for the K+M-experimental arm trial
FWER2, the family-wise error rate for the K+M-experimental arm trial.
delta, the standardized clinical effect size
expected to be detected in the trial
save, the number of patients saved in the K+M-experimental arm trial compared to
conducting one K-experimental arm and one M-experimental arm trial, separately.
Author(s)
Xiaomeng Yuan, Haitao Pan
References
Pan, H., Yuan, X. and Ye, J. (2022). An optimal two-period multiarm
platform design with new experimental arms added during the trial. Manuscript submitted for
publication.
Dunnett, C. W. (1955). A multiple comparison procedure for comparing
several treatments with a control. Journal of the American Statistical
Association, 50(272), 1096-1121.
Examples
# control fwer
one_design(n2 = 107, n0_2 = 198, nt = 30, K = 2, M = 2, fwer = 0.025,
marginal.power = 0.8, delta = 0.4)
#$design_Karm
# K n1 n0_1 N1 z_alpha1 FWER1 z_beta1 Power1 cor0 delta
#1 2 101 143 345 2.220604 0.025 0.8416212 0.9222971 0.4142136 0.4
#
#$designs
# n2 n0_2 nt n0t nc N2 A1 A2 cor1 cor2 critical_value2
#1 107 198 30 43 241 669 1.414214 2.012987 0.3508197 0.2746316 2.475233
#
# marginal.power2 disjunctive.power2 FWER2 delta save
#1 0.80011 0.9853799 0.025 0.4 21
#
# control pwer
one_design(n2 = 76, n0_2 = 140, nt = 30, K = 2, M = 2, pwer = 0.025,
marginal.power = 0.8, delta = 0.4)
#$design_Karm
# K n1 n0_1 N1 z_alpha1 FWER1 z_beta1 Power1 cor0 delta
#1 2 84 119 287 1.959964 0.04647892 0.8416212 0.9222971 0.4142136 0.4
#
#$designs
# n2 n0_2 nt n0t nc N2 A1 A2 cor1 cor2 critical_value2
#1 76 140 30 43 183 487 1.414214 2.108696 0.3518519 0.2437831 1.959964
# marginal.power2 disjunctive.power2 FWER2 delta save
#1 0.8001424 0.9867451 0.08807302 0.4 87