Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions.

ABSTRACT: Studies that generate real-world evidence on the effects of medical products through analysis of digital data collected in clinical practice provide key insights for regulators, payers, and other healthcare decision-makers. Ensuring reproducibility of such findings is fundamental to effective evidence-based decision-making. We reproduce results for 150 studies published in peer-reviewed journals using the same healthcare databases as original investigators and evaluate the completeness of reporting for 250. Original and reproduction effect sizes were positively correlated (Pearson's correlation = 0.85), a strong relationship with some room for improvement. The median and interquartile range for the relative magnitude of effect (e.g., hazard ratio_original/hazard ratio_reprodu

SUBMITTER: Wang SV 

PROVIDER: S-EPMC9430007 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature