6 research outputs found

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

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    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 ratiooriginal/hazard ratioreproduction) is 1.0 [0.9, 1.1], range [0.3, 2.1]. While the majority of results are closely reproduced, a subset are not. The latter can be explained by incomplete reporting and updated data. Greater methodological transparency aligned with new guidance may further improve reproducibility and validity assessment, thus facilitating evidence-based decision-making. Study registration number: EUPAS19636

    Reproducible Evidence: Practices to Enhance and Achieve Transparency (REPEAT)

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    Studies that generate real-world evidence (RWE) through analysis of routinely collected healthcare data provide key insights for regulators, payers, and other healthcare decision-makers. In this project, we evaluated clarity of methodology reporting for 250 RWE studies and attempted to reproduce 150 studies using the same data sources and methods reported by the original investigators
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