Abstract

The level of trust in health economics and outcomes research studies has been an ongoing concern owing to the funding or conduct of studies by commercial organizations and the disagreements over some of the methodological approaches used. Attempts have been made to improve or standardize methods,¹ establish ethical codes of practice,² and improve transparency in the reporting of studies.³

The article by Orsini et al⁴ discusses improving the level of transparency, trust, and research replicability of real-world evidence studies, particularly those for testing hypotheses for evaluating the effectiveness of treatments. These authors define real-world evidence studies as those using data from electronic health records, claims and billing databases, product and disease registries, wearable devices, and electronic applications. These use different study designs and analyses, such as pragmatic randomized trials and prospective or retrospective observational studies.