EPsProg_bias | R Documentation |
To discount for overoptimistic results in phase II when calculating the optimal sample size in phase III, it is necessary to use the following functions, which each describe a specific case:
EPsProg_L()
: calculates the expected probability of a successful for an additive adjustment factor (i.e. adjust the lower bound of the one-sided confidence interval),
however the go-decision is not affected by the bias adjustment
EPsProg_L2()
: calculates the expected probability of a successful for an additive adjustment factor (i.e. adjust the lower bound of the one-sided confidence interval)
when the go-decision is also affected by the bias adjustment
EPsProg_R()
: calculates the expected probability of a successful for a multiplicative adjustment factor (i.e. use estimate with a retention factor),
however the go-decision is not affected by the bias adjustment
EPsProg_R2()
: calculates the expected probability of a successful for a multiplicative adjustment factor (i.e. use estimate with a retention factor)
when the go-decision is also affected by the bias adjustment
EPsProg_L(
HRgo,
d2,
Adj,
alpha,
beta,
step1,
step2,
w,
hr1,
hr2,
id1,
id2,
fixed
)
EPsProg_L2(
HRgo,
d2,
Adj,
alpha,
beta,
step1,
step2,
w,
hr1,
hr2,
id1,
id2,
fixed
)
EPsProg_R(
HRgo,
d2,
Adj,
alpha,
beta,
step1,
step2,
w,
hr1,
hr2,
id1,
id2,
fixed
)
EPsProg_R2(
HRgo,
d2,
Adj,
alpha,
beta,
step1,
step2,
w,
hr1,
hr2,
id1,
id2,
fixed
)
HRgo |
threshold value for the go/no-go decision rule |
d2 |
total events for phase II; must be even number |
Adj |
adjustment parameter |
alpha |
significance level |
beta |
|
step1 |
lower boundary for effect size |
step2 |
upper boundary for effect size |
w |
weight for mixture prior distribution |
hr1 |
first assumed true treatment effect on HR scale for prior distribution |
hr2 |
second assumed true treatment effect on HR scale for prior distribution |
id1 |
amount of information for |
id2 |
amount of information for |
fixed |
choose if true treatment effects are fixed or random, if TRUE |
The output of the functions EPsProg_L()
, EPsProg_L2()
, EPsProg_R()
and EPsProg_R2()
is the expected probability of a successful program.
res <- EPsProg_L(HRgo = 0.8, d2 = 50, Adj = 0.4,
alpha = 0.025, beta = 0.1,
step1 = 1, step2 = 0.95,
w = 0.3, hr1 = 0.69, hr2 = 0.81,
id1 = 280, id2 = 420, fixed = FALSE)
res <- EPsProg_L2(HRgo = 0.8, d2 = 50, Adj = 0.4,
alpha = 0.025, beta = 0.1,
step1 = 1, step2 = 0.95,
w = 0.3, hr1 = 0.69, hr2 = 0.81,
id1 = 280, id2 = 420, fixed = FALSE)
res <- EPsProg_R(HRgo = 0.8, d2 = 50, Adj = 0.9,
alpha = 0.025, beta = 0.1,
step1 = 1, step2 = 0.95,
w = 0.3, hr1 = 0.69, hr2 = 0.81,
id1 = 280, id2 = 420, fixed = FALSE)
res <- EPsProg_R2(HRgo = 0.8, d2 = 50, Adj = 0.9,
alpha = 0.025, beta = 0.1,
step1 = 1, step2 = 0.95,
w = 0.3, hr1 = 0.69, hr2 = 0.81,
id1 = 280, id2 = 420, fixed = FALSE)
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