secondaryBoundaryVec {gsrsb}

Calculate Refined Secondary Boundaries and Nominal Significance

Description

Refined secondary boundaries, and nominal significance for the secondary endpoint are calculated.

Usage

secondaryBoundaryVec(
  alpha,
  tVec,
  pOBF = TRUE,
  sOBF = FALSE,
  LanDeMets = FALSE,
  initIntvl = c(0.8, 8)
)

Arguments

alpha

type I error probability.

tVec

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

pOBF

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

sOBF

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

LanDeMets

type of boundary, TRUE is the error spending approach, FALSE is the original approach.

initIntvl

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

Details

This function gives a list including refined secondary boundary and the nominal significance for the secondary endpoint. There are a computing parameter initIntvl. Parameter initIntvl contains the end-points of the interval to be searched for the root. For Lan-DeMets error spending approach, the lower end point should choose a number slightly less than 1, and the upper end point should choose a number between 4 and 10.

Value

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

Author(s)

Jiangtao Gou

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.

Lan, K. K. G., and Demets, D. L. (1983). Discrete sequential boundaries for clinical trials. Biometrika 70, 659-663.

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

secondaryBoundaryVecLD, secondaryBoundaryVecOrig

Examples

require(mvtnorm)
require(ldbounds)
result <- secondaryBoundaryVec(alpha=0.025,tVec=c(1/2,1),pOBF=TRUE,sOBF=FALSE,
       LanDeMets=FALSE,initIntvl=c(0.8,5))
result$secondaryBoundary
result$nomialSignificance