gsrsb (version 1.2.1)

secondaryBoundaryVecOrig: Calculate Refined Secondary Boundaries and Nominal Significance, Standard Approach

Description

Standard refined secondary boundaries, and nominal significance for the secondary endpoint are calculated by using the standard (original) approach.

Usage

secondaryBoundaryVecOrig(
  alpha,
  tVec,
  primaryOBF = TRUE,
  secondaryOBF = FALSE,
  initIntvl = c(1, 8)
)

Value

a result list including standard refined secondary boundary and the nominal significance for the secondary endpoint.

Arguments

alpha

type I error probability.

tVec

vector of relative information levels. The last element in the vector is 1.

primaryOBF

type of primary boundary, TURE is the O'Brien-Fleming boundary, FALSE is the Pocock boundary.

secondaryOBF

type of secondary boundary, TURE is the O'Brien-Fleming boundary, FALSE is the Pocock boundary.

initIntvl

computing paramter, a pair of numbers containing the end-points of the interval to be searched for the root.

Author

Jiangtao Gou

Details

This function uses the standard approach (O'Brien and Fleming 1979, Pocock 1977), and gives a list including refined secondary boundary and the nominal significance for the secondary endpoint. There is a computing parameter initIntvl. Parameter initIntvl contains the end-points of the interval to be searched for the root. The lower end point should choose a number around 1, and the upper end point should choose a number between 4 and 10.

References

Glimm, E., Maurer, W., and Bretz, F. (2010). Hierarchical testing of multiple endpoints in group-sequential trials. Statistics in Medicine 29, 219-228.

Hung, H. M. J., Wang, S.-J., and O'Neill, R. (2007). Statistical considerations for testing multiple endpoints in group sequential or adaptive clinical trials. Journal of Biopharmaceutical Statistics 17, 1201-1210.

Jennison, C. and Turnbull, B. W. (2000). Group Sequential Methods with Applications to Clinical Trials. Chapman and Hall/CRC, New York.

O'Brien, P. C., and Fleming, T. R. (1979). A multiple testing procedure for clinical trials. Biometrics 35, 549-556.

Pocock, S. J. (1977). Group sequential methods in the design and analysis of clinical trials. Biometrika 64, 191-199.

Tamhane, A. C., Mehta, C. R., and Liu, L. (2010). Testing a primary and a secondary endpoint in a group sequential design. Biometrics 66, 1174-1184.

Tamhane, A. C., Gou, J., Jennison, C., Mehta, C. R., and Curto, T. (2018). A gatekeeping procedure to test a primary and a secondary endpoint in a group sequential design with multiple interim looks. Biometrics, 74, 40-48.

See Also

secondaryBoundaryVec, secondaryBoundaryVecLD

Examples

require(mvtnorm)
require(ldbounds)
result <- secondaryBoundaryVecOrig(alpha=0.025,tVec=c(1/2,1),primaryOBF=TRUE,
       secondaryOBF=FALSE, initIntvl=c(1,4))
result$secondaryBoundary
result$nomialSignificance