Reproducibility in pharmacometrics applied in a phase III trial of BCG-vaccination for COVID-19.

ABSTRACT: Large clinical trials often generate complex and large datasets which need to be presented frequently throughout the trial for interim analysis or to inform a data safety monitory board (DSMB). In addition, reliable and traceability are required to ensure reproducibility in pharmacometric data analysis. A reproducible pharmacometric analysis workflow was developed during a large clinical trial involving 1000 participants over one year testing Bacillus Calmette-Guérin (BCG) (re)vaccination in coronavirus disease 2019 (COVID-19) morbidity and mortality in frontline health care workers. The workflow was designed to review data iteratively during the trial, compile frequent reports to the DSMB, and prepare for rapid pharmacometric analysis. Clinical trial datasets (n = 41) were transferred ite

SUBMITTER: van Wijk RC 

PROVIDER: S-EPMC10539503 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature