EffDesign: HCT design with interim monitoring for efficacy only

In HCTDesign: Group Sequential Design for Historical Control Trial with Survival Outcome

HCT design with interim monitoring for efficacy only

Description

The group sequential design for historical controlled survival outcome trials with efficacy boundaries only.

Usage

EffDesign(
  k,
  alpha,
  beta,
  delta,
  delta0,
  d1,
  option = "OBF",
  param = 4,
  trial = "Superiority"
)

Arguments

k	vector of time fraction for all planned looks: k=c(1/3,2/3,1) if the three planned looks will be carried out at 1/3, 2/3 and all of the total events in the experiment arm.
alpha	type I error.
beta	type II error.
delta	hazard ratio: hazard of experiment group over hazard of control group.
delta0	Non-inferiority margin.
d1	total number of events in the historical control group.
option	type of spending function: "OBF", "Gamma", "Rho" or "Pocock". Default is "OBF.
param	Parameter for Gamma family or Rho family. Default value is 4.
trial	Type of trial: "Superiority" or "Non-inferiority". Default is "Superiority".

Value

List of dataframes and vectors containing the details about the following: design of the trial which includes the number of looks and events; details about futility and efficacy boundaries which include transformed information time at each look, cumulative beta and alpha respectively, p-values and crossing probabilities; etam(drift parameter); d2max(maximum number of events in the experimental group); delta_used(hazard ratio used in the design).

Author(s)

Tushar Patni, Yimei Li, Jianrong Wu, and Arzu Onar-Thomas.

References

\insertRef

doi:10.1002/pst.1756HCTDesign

\insertRef

doi:10.1080/10543406.2019.1684305HCTDesign

Examples

#Superiority trial with three equally spaced looks for efficacy using OBF spending function.
gg<-EffDesign(k=c(0.3,0.6,1),alpha=0.05,beta=0.1,delta=0.57,d1=65,option="OBF",trial="Superiority")

HCTDesign documentation built on Aug. 29, 2025, 5:23 p.m.