Reproducibility and replicability of high-frequency, in-home digital biomarkers in reducing sample sizes for clinical trials.

INTRODUCTION

Reproducibility and replicability of results are rarely achieved for digital biomarkers analyses. We reproduced and replicated previously reported sample size estimates based on digital biomarker and neuropsychological test outcomes in a hypothetical 4-year early-phase Alzheimer's disease trial.

METHODS

Original data and newly collected data (using a different motion sensor) came from the Oregon Center for Aging & Technology (ORCATECH). Given trajectories of those with incident mild cognitive impairment and normal cognition would represent trajectories of the control and experimental groups in a hypothetical trial, sample sizes to provide 80% power to detect effect sizes ranging from 20% to 50% were calculated.

RESULTS

For the reproducibility, identical -values and slope estimates were found with both digital biomarkers and neuropsychological test measures between the previous and current studies. As for the replicability, a greater correlation was found between original and replicated sample size estimates for digital biomarkers ( = 0.87,  < .001) than neuropsychological test outcomes ( = 0.75, < .001).

DISCUSSION

Reproducibility and replicability of digital biomarker analyses are feasible and encouraged to establish the reliability of findings.