Group Sequential Clinical Trial Designs for Composite Endpoints


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Documentation for package ‘gsMeanFreq’ version 0.1.0

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Apply.calendar.censoring Function to apply a given calendar time as effective censoring time.
Apply.calendar.censoring.2 Function to apply a given calendar time as effective censoring time for two-sample composite endpoint data.
find.beta.trt Function to solve for treatment effect size given target power for two-sample tests.
find.c Function to solve for a group sequential critical value at a given stage
find.Delta.given.power Function to solve for the mean frequency effect size given target power for one-sample simulations.
find.lambda_0.given.Delta Function to solve for the baseline recurrent event rate given a mean frequency difference for one-sample simulations.
find.lambda_0.given.mu0 Function to solve for the baseline recurrent event rate given a target mean frequency for one-sample simulations.
OBF O'Brien-Flemming error spending function.
OneSample.Estimator.sequential Function to estimate the one-sample mean frequency under a group sequential design.
Onesample.generate.sequential Function to simulate one-sample composite endpoint data under staggered entry.
Solve.beta.given.power Function to solve for the treatment effect parameter to achieve target power by Monte Carlo simulation.
True.mu Function to calculate the true value of the mean frequency function.
TwoSample.Boundary.TTFE Function to calculate the sequential rejection boundaries for the time-to-first-event (TTFE) method.
TwoSample.Constant.GT Function to compute calibration constants for the two-sample generalized-t statistics.
TwoSample.Constant.LR Function to compute calibration constants for the two-sample generalized log-rank statistics.
TwoSample.Estimator.GT.sequential Function to calculate the two-sample generalized-t statistic for composite endpoint under sequential monitoring.
TwoSample.Estimator.LR.sequential Function to calculate the two-sample generalized log-rank statistic for composite endpoint under sequential monitoring.
TwoSample.Estimator.TTFE.sequential Function to calculate the Z statistics and variance for the time-to-first-event (TTFE) method.
TwoSample.generate.sequential Function to simulate two-sample composite endpoint data under staggered entry.
TwoSample.Q.Cov.Estimator.Sequential.GT Function to calculate stage-wise test statistics, variances, and correlation for two-sample generalized-t statistics.
TwoSample.Q.Cov.Estimator.Sequential.LR Function to calculate stage-wise test statistics, variances, and correlation for two-sample generalized log-rank statistics.
TwoSample.Wald.and.Boundary Function to calculate the Wald statistics and group sequential boundaries for two-sample monitoring.
TwoSample.Z.Var.Estimator.Sequential.TTFE Function to calculate the two-sample time-to-first-event (TTFE) statistics and variances across multiple calendar times.