SM: Sample size in terms of number of subjects in the...

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

Sample size in terms of number of subjects in the experimental group

Description

Calculates the total number of subjects for the experimental group using the total number of events(d2max:the output from design functions) and the estimated failure probability based on the person level historical control data and proportional hazard assumption.

Usage

SM(time, event, d2max, opt = "KM", event_ind, ta, tf, delta)

Arguments

time	event time vector from person level historical control data.
event	numeric vector indicating the status of event from person level historical control data.
d2max	maximum number of events in the experimental group calculated from the design function.
opt	the method of fitting survival curve-"log_normal" or "KM" (log-normal or Kaplan Meier). Default is "KM".
event_ind	numeric value indicating the occurrence of event.
ta	enrollment time.
tf	follow-up time.
delta	hazard ratio.

Value

Returns the value of sample size.

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

time<-c(20,65,12,50,58,65,45,44)
event<-c(1,0,0,0,1,1,1,1)
d2max=57
gg<-SM(time,event,d2max,opt="log_normal",ta=4,tf=3,delta=0.57,event_ind=1)

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