dtl_app_sim_single {dtlcor}R Documentation

Simulate a single drop-the-losers (DTL) trial.

Description

Simulate a single trial based on the DTL design

Usage

dtl_app_sim_single(
  D,
  N,
  n,
  mPFS,
  q,
  gamma,
  drop_rate,
  enroll,
  interim_t,
  sel_g_func = sel_g_func_default,
  ...
)

Arguments

D

Total number of events.

N

Total number of patients in both selected and control arms at final analysis.

n

Number of patients per treatment arm at the DTL look.

mPFS

A 3-entry vector of median progression-free survival times for control, low dose and high dose arms (assume exponential time-to-event outcome for all arms and the conditional distribution for responders and non-responders can be uniquely identified given q and gamma).

q

A 3-entry vector of response rates under the null.

gamma

Hazards ratio of responders and non-responders.

drop_rate

Annual drop-out rate.

enroll

Annual Enrollment rate.

interim_t

A vector of information fractions of final stage.

sel_g_func

Arm-select function. The default function is sel_g_func_default(W_2, W_1, delta). Users can define their own arm-select function. The format of the function must be function_name(W_2, W_1, ...). The return values must be 1 (arm 1 is selected) or 2 (arm 2 is selected) or 0 (stop for futility).

...

Other arguments from sel_g_func.

Value

A list including (1) a data frame of response rates of low dose and high dose W_1, W_2 and the log-rank test statistics Z_jk at kth interim analysis if the jth arm is selected at DTL look; (2) data frames of simulated data at DTL look; (3) data frames of simulated data at interim or final analyses.

Examples

# Inputs
set.seed(1000)
D           = 162
N           = 152  
n           = 80    
mPFS        = c(180, 276, 300)
q           = c(0.2, 0.4, 0.5)
gamma       = 0.15
drop_rate   = 0.05
enroll      = 20 * 12
interim_t   = c(0.5, 1)
delta       = 0.05  

# Run function
dtl_app_sim_single(D, N, n, mPFS, q, gamma, drop_rate, enroll, interim_t, delta = delta)
                  

[Package dtlcor version 0.1.0 Index]