Set up an open-label extension (OLE) analysis

Bundles data, column mappings, crossover time, and a method object into an analysis object ready to be passed to run_analysis.

Usage

setup_analysis_OLE(
  data,
  trial_status_col_name,
  treatment_col_name,
  outcome_col_name,
  covariates_col_name,
  method_OLE_obj,
  T_cross,
  alpha = 0.05
)

Arguments

data

A data frame containing all subject-level data.

trial_status_col_name

Name of the trial status column.

treatment_col_name

Name of the treatment column.

outcome_col_name

Character vector of outcome column names covering both placebo-controlled and OLE periods.

covariates_col_name

Character vector of covariate column names.

method_OLE_obj

A method object created by did_ec_ipw, did_ec_aipw, did_ec_or, or scm.

T_cross

Integer crossover time point. The first T_cross outcomes are from the placebo-controlled phase; the rest are OLE.

alpha

Significance level (default 0.05).

Value

An object of class analysis_OLE_obj, to be passed to run_analysis.

Details

Available OLE methods:

did_ec_ipw

Difference-in-differences with IPW.

did_ec_aipw

DID with augmented IPW.

did_ec_or

DID with outcome regression.

scm

Synthetic control method.

See also

run_analysis, setup_analysis_primary

Examples

method <- did_ec_ipw(
  ps_formula = "S ~ x1 + x2 + x3 + x4 + x5",
  trt_formula = "A ~ x1 + x2 + x3 + x4 + x5",
  bootstrap = 50
)
setup_analysis_OLE(
  data = SyntheticData,
  trial_status_col_name = "S",
  treatment_col_name = "A",
  outcome_col_name = c("y1", "y2", "y3", "y4"),
  covariates_col_name = c("x1", "x2", "x3", "x4", "x5"),
  method_OLE_obj = method,
  T_cross = 2
)
#> <analysis_OLE_obj>
#>   Observations: 300 
#>   Trial status: S 
#>   Treatment: A 
#>   Outcomes: y1, y2, y3, y4 
#>   Covariates: x1, x2, x3, x4, x5 
#>   Method: DID-EC-IPW 
#>   T_cross: 2 
#>   Alpha: 0.05