A computer program for designing clinical trials with arbitrary survival curves and group sequential testing.
We present a program, mhghseq, for designing a clinical trial to compare two treatments. For a user-specified hypothesis and a user-specified alternative, mhghseq finds the number of subjects required to achieve a given size and power. It permits each treatment to have an arbitrary survival curve and it allows for group sequential testing. It provides solutions for small samples as well as for large samples. There may be a follow-up period after accrual is completed. Tests may be one or two-sided, either the log-rank or the Gehan test may be used, and either of two commonly used boundary forms--the O'Brien-Fleming or Pocock boundary forms--may be specified. Although mhghseq relies primarily on simulation to produce results, the large sample sequential boundary for the log-rank test optionally may be computed with an algorithm given here that is different from ones used in the past for this purpose.
Halpern
J
J
Department of Health Research and Policy, Stanford University Medical School, California 94305.
Brown
B W
BW
D003198:Computer Simulation; D003201:Computers; D005260:Female; D006801:Humans; D008297:Male; D012107:Research Design