Optimising research investment by simulating and evaluating monitoring strategies to inform a trial: a simulation of liver fibrosis monitoring.

ABSTRACT:

Background

The aim of the study was to investigate the development of evidence-based monitoring strategies in a population with progressive or recurrent disease. A simulation study of monitoring strategies using a new biomarker (ELF) for the detection of liver cirrhosis in people with known liver fibrosis was undertaken alongside a randomised controlled trial (ELUCIDATE).

Methods

Existing data and expert opinion were used to estimate the progression of disease and the performance of repeat testing with ELF. Knowledge of the true disease status in addition to the observed test results for a cohort of simulated patients allowed various monitoring strategies to be implemented, evaluated and validated against trial data.

Results

Several monitoring strategies ranging in co

SUBMITTER: Sitch AJ 

PROVIDER: S-EPMC11660973 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature