CDISC Pilot Replication

A modern rebuild of the CDISC pilot clinical tables

This site documents the CDISC Pilot Replication project: a full reproduction of the 30 safety and efficacy tables from the CDISC pilot study, rebuilt with a modern, open-source R reporting stack and rendered as Word (.docx) documents that are visually faithful to the original 2020 RTF outputs.

The stack

Concern Package
Table summaries (counts, descriptive stats, shifts) tplyr2
Table styling → DOCX clinify
Mixed-model repeated measures (MMRM) mmrm
Cochran–Mantel–Haenszel tests coin
Data wrangling tidyverse
Reproducible environment renv

Explore

  • Outputs — browse all 30 tables, each with an in-page PDF viewer and downloads.
  • Code Reference — the setup, helpers, shared builders, and every table program, with source.
  • About — the original reproduction and the 2026 revisit.
Note

Every output is verified against the original RTF with a pixel-diff / content-diff fidelity harness. Where a value differs by design (e.g. modern MMRM vs. the legacy random-slope fit), the divergence is documented rather than cloned.