Introduction to metalite.sl

library(metalite)
library(metalite.sl)

Overview

metalite.sl R package designed for the analysis & reporting of subject-level analysis in clinical trials. It operates on ADaM datasets and adheres to the metalite structure. The package encompasses the following components:

Baseline Characteristics.

This R package offers a comprehensive software development lifecycle (SDLC) solution, encompassing activities such as definition, development, validation, and finalization of the analysis.

Highlighted features

Workflow

The overall workflow includes the following steps:

  1. Define metadata information using metalite R package.
  2. Prepare outdata using prepare_*() functions.
  3. Extend outdata using extend_*() functions (optional).
  4. Format outdata using format_*() functions.
  5. Create TLFs using tlf_*() functions.

For instance, we can illustrate the creation of a straightforward Baseline characteristic table as shown below.

meta_sl_example() |>
  prepare_base_char(
    population = "apat",
    analysis = "base_char",
    parameter = "age;gender"
  ) |>
  format_base_char() |>
  rtf_base_char(
    source = "Source: [CDISCpilot: adam-adsl]",
    path_outdata = tempfile(fileext = ".Rdata"),
    path_outtable = tempfile(fileext = ".rtf")
  )

An example for interactive baseline characteristic table:

react_base_char(
  metadata_sl = meta_sl_example(),
  metadata_ae = metalite.ae::meta_ae_example(),
  population = "apat",
  observation = "wk12",
  display_total = TRUE,
  sl_parameter = "age;race",
  ae_subgroup = c("age", "race"),
  ae_specific = "rel",
  width = 1200
)
Placebo
Low Dose
High Dose
Total
n
(%)
n
(%)
n
(%)
n
(%)
Participants in population (1)
Age (years) (10)
Race (3)

Additional examples and tutorials can be found on the package website, offering further guidance and illustrations.

Input

To implement the workflow in metalite.sl, it is necessary to establish a metadata structure using the metalite R package. For detailed instructions, please consult the metalite tutorial and refer to the source code of the function meta_sl_example().