nRec: the number of patients recruited every year. Length(nRec) is the number of years of recruitment
nFUp: the number of additional years of followup
pi0: the probability of response under control arm
pi1: the probability of response under treatment arm
theta: the three dimensional parameter (α,β,γ) of the joint response/survival model
lambda0: the baseline hazard rate
blockSize: the size of the blocks for randomization of the treatment/control; we use block randomization
Details
Generates data from an exponentail distribution according to the model and adhering to the recruitment goals for each calendar year
Returns
A data frame consisting of the following variables. - entryTime: entry time of the patient into the trial
responseIndicator: an indicator of patient being a responder or not
treatmentIndicator: an indicator of patient being in treatment arm or control
timeToEvent: the time to event or death in the language of the paper
References
Lai, Tze Leung and Lavori, Philip W. and Shih, Mei-Chiung. Sequential Design of Phase II-III Cancer Trials, Statistics in Medicine, Volume 31, issue 18, p.1944-1960, 2012.
Author(s)
Mei-Chiung Shih, Balasubramanian Narasimhan, Pei He