optimal | R Documentation |
Find the optimal parameters used in the get_oc()
function
optimal(shape, m0, ms, tf, ta, tot_size, dist)
shape |
the shape parameter of weibull distribution |
m0 |
the median survival time of historical data |
ms |
the minimal clinical meaningful median survival time |
tf |
the follow-up duration |
ta |
the accrual duration |
tot_size |
the required sample size for each arm |
dist |
the distribution |
optimal()
returns a list containing two blocks:
$param
:
(1) S0: historical survival probability at the landmark time point x0 (2) hr: hazard ratio of the hypothetical arm with “minimal clinical meaningful median survival time” to the historical arm (3) rate: accrual rate (calculated as tot_size/ta)
$Two_stage
:
(1) alpha: type I error (2) beta: type II error (3) n1: the required sample size for the first stage (4) c1: the cutoff point at the first stage (5) n: the required sample size for each arm (is equal to tot_size) (6) c: the cutoff point at the final stage (7) t1: the expected time of interim analysis (first stage) (8) MTSL: the maximum total study length (ta + tf) (9) ESS: the expected sample size for each arm (10) PS: the probability of early stopping
(1) For optimal()
function, if the ms is set to be equal to the less effective arm (e.g., say, the arm A is less effective than the arm B), with the rationale, by this way, the computed boundaries, c1, n1, c, would control the pre-specified type I (since both arms A and B are all under the same null case) while the power for the better arm B, would have at least pre-specified power 1-beta
(2) optimal()
funcition will be applied to either two or three-arm cases to find the optimal cutoff bounaries, c1, n1, c
Chia-Wei Hsu, Haitao Pan, Jianrong Wu
Jianrong Wu, Haitao Pan, Chia-Wei Hsu (2021). "Two-Stage Screened Selection Designs for Randomized Phase II Trials with Time-to-Event Endpoints." Submitted
## For 2 arms ## Not run: shape <- 1 m0 <- 1 ms <- 2.4 tf <- 3 ta <- 24 tot_size <- 19 dist <- "WB" optimal(shape = shape, m0 = m0, ms = ms, tf = tf, ta = ta, tot_size = tot_size, dist = dist) ## End(Not run) ## For 3 arms ## Not run: shape <- 1 m0 <- 1 ms <- 2 tf <- 3 ta <- 24 tot_size <- 21 dist <- "WB" optimal(shape = shape, m0 = m0, ms = ms, tf = tf, ta = ta, tot_size = tot_size, dist = dist) ## End(Not run)
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