rmsamplesize1s: Sample Size for One-Sample Restricted Mean Survival Time

In lrstat: Power and Sample Size Calculation for Non-Proportional Hazards and Beyond

Sample Size for One-Sample Restricted Mean Survival Time

Description

Obtains the needed accrual duration given power and follow-up time, the needed follow-up time given power and accrual duration, or the needed absolute accrual rates given power, accrual duration, follow-up duration, and relative accrual rates in a one-group survival design.

Usage

rmsamplesize1s(
  beta = 0.2,
  kMax = 1L,
  informationRates = NA_real_,
  efficacyStopping = NA_integer_,
  futilityStopping = NA_integer_,
  criticalValues = NA_real_,
  alpha = 0.025,
  typeAlphaSpending = "sfOF",
  parameterAlphaSpending = NA_real_,
  userAlphaSpending = NA_real_,
  futilityBounds = NA_real_,
  typeBetaSpending = "none",
  parameterBetaSpending = NA_real_,
  userBetaSpending = NA_real_,
  milestone = NA_real_,
  rmstH0 = NA_real_,
  accrualTime = 0L,
  accrualIntensity = NA_real_,
  piecewiseSurvivalTime = 0L,
  stratumFraction = 1L,
  lambda = NA_real_,
  gamma = 0L,
  accrualDuration = NA_real_,
  followupTime = NA_real_,
  fixedFollowup = 0L,
  interval = as.numeric(c(0.001, 240)),
  spendingTime = NA_real_,
  rounding = 1L
)

Arguments

beta	Type II error. Defaults to 0.2.
kMax	The maximum number of stages.
informationRates	The information rates. Defaults to (1:kMax) / kMax if left unspecified.
efficacyStopping	Indicators of whether efficacy stopping is allowed at each stage. Defaults to true if left unspecified.
futilityStopping	Indicators of whether futility stopping is allowed at each stage. Defaults to true if left unspecified.
criticalValues	Upper boundaries on the z-test statistic scale for stopping for efficacy.
alpha	The significance level. Defaults to 0.025.
typeAlphaSpending	The type of alpha spending. One of the following: "OF" for O'Brien-Fleming boundaries, "P" for Pocock boundaries, "WT" for Wang & Tsiatis boundaries, "sfOF" for O'Brien-Fleming type spending function, "sfP" for Pocock type spending function, "sfKD" for Kim & DeMets spending function, "sfHSD" for Hwang, Shi & DeCani spending function, "user" for user defined spending, and "none" for no early efficacy stopping. Defaults to "sfOF".
parameterAlphaSpending	The parameter value for the alpha spending. Corresponds to Delta for "WT", rho for "sfKD", and gamma for "sfHSD".
userAlphaSpending	The user defined alpha spending. Cumulative alpha spent up to each stage.
futilityBounds	Lower boundaries on the z-test statistic scale for stopping for futility at stages 1, ..., kMax-1. Defaults to rep(-6, kMax-1) if left unspecified. The futility bounds are non-binding for the calculation of critical values.
typeBetaSpending	The type of beta spending. One of the following: "sfOF" for O'Brien-Fleming type spending function, "sfP" for Pocock type spending function, "sfKD" for Kim & DeMets spending function, "sfHSD" for Hwang, Shi & DeCani spending function, "user" for user defined spending, and "none" for no early futility stopping. Defaults to "none".
parameterBetaSpending	The parameter value for the beta spending. Corresponds to rho for "sfKD", and gamma for "sfHSD".
userBetaSpending	The user defined beta spending. Cumulative beta spent up to each stage.
milestone	The milestone time at which to calculate the restricted survival time.
rmstH0	The restricted mean survival time under the null hypothesis.
accrualTime	A vector that specifies the starting time of piecewise Poisson enrollment time intervals. Must start with 0, e.g., c(0, 3) breaks the time axis into 2 accrual intervals: [0, 3) and [3, Inf).
accrualIntensity	A vector of accrual intensities. One for each accrual time interval.
piecewiseSurvivalTime	A vector that specifies the starting time of piecewise exponential survival time intervals. Must start with 0, e.g., c(0, 6) breaks the time axis into 2 event intervals: [0, 6) and [6, Inf). Defaults to 0 for exponential distribution.
stratumFraction	A vector of stratum fractions that sum to 1. Defaults to 1 for no stratification.
lambda	A vector of hazard rates for the event in each analysis time interval by stratum under the alternative hypothesis.
gamma	The hazard rate for exponential dropout or a vector of hazard rates for piecewise exponential dropout. Defaults to 0 for no dropout.
accrualDuration	Duration of the enrollment period.
followupTime	Follow-up time for the last enrolled subject.
fixedFollowup	Whether a fixed follow-up design is used. Defaults to 0 for variable follow-up.
interval	The interval to search for the solution of accrualDuration, followupDuration, or the proportionality constant of accrualIntensity. Defaults to c(0.001, 240).
spendingTime	A vector of length kMax for the error spending time at each analysis. Defaults to missing, in which case, it is the same as informationRates.
rounding	Whether to round up sample size. Defaults to 1 for sample size rounding.

Value

A list of two components:

• resultsUnderH1: An S3 class rmpower1s object under the alternative hypothesis.

• resultsUnderH0: An S3 class rmpower1s object under the null hypothesis.

Author(s)

Kaifeng Lu, [e-mail]

See Also

rmpower1s

Examples

# Example 1: Obtains follow-up duration given power, accrual intensity,
# and accrual duration for variable follow-up

rmsamplesize1s(beta = 0.2, kMax = 2,
               informationRates = c(0.8, 1),
               alpha = 0.025, typeAlphaSpending = "sfOF",
               milestone = 18, rmstH0 = 10,
               accrualTime = seq(0, 8),
               accrualIntensity = 26/9*seq(1, 9),
               piecewiseSurvivalTime = c(0, 6),
               stratumFraction = c(0.2, 0.8),
               lambda = c(0.0533, 0.0309, 1.5*0.0533, 1.5*0.0309),
               gamma = -log(1-0.05)/12, accrualDuration = 22,
               followupTime = NA, fixedFollowup = FALSE)

# Example 2: Obtains accrual intensity given power, accrual duration, and
# follow-up duration for variable follow-up

rmsamplesize1s(beta = 0.2, kMax = 2,
               informationRates = c(0.8, 1),
               alpha = 0.025, typeAlphaSpending = "sfOF",
               milestone = 18, rmstH0 = 10,
               accrualTime = seq(0, 8),
               accrualIntensity = 26/9*seq(1, 9),
               piecewiseSurvivalTime = c(0, 6),
               stratumFraction = c(0.2, 0.8),
               lambda = c(0.0533, 0.0309, 1.5*0.0533, 1.5*0.0309),
               gamma = -log(1-0.05)/12, accrualDuration = 22,
               followupTime = 18, fixedFollowup = FALSE)


# Example 3: Obtains accrual duration given power, accrual intensity, and
# follow-up duration for fixed follow-up

rmsamplesize1s(beta = 0.2, kMax = 2,
               informationRates = c(0.8, 1),
               alpha = 0.025, typeAlphaSpending = "sfOF",
               milestone = 18, rmstH0 = 10,
               accrualTime = seq(0, 8),
               accrualIntensity = 26/9*seq(1, 9),
               piecewiseSurvivalTime = c(0, 6),
               stratumFraction = c(0.2, 0.8),
               lambda = c(0.0533, 0.0309, 1.5*0.0533, 1.5*0.0309),
               gamma = -log(1-0.05)/12, accrualDuration = NA,
               followupTime = 18, fixedFollowup = TRUE)

lrstat documentation built on Oct. 18, 2024, 9:06 a.m.