Building transparency and reproducibility into the practice of pharmacoepidemiology and outcomes research.

ABSTRACT

Real-world evidence (RWE) studies are increasingly used to inform policy and clinical decisions. However, there remain concerns about the credibility and reproducibility of RWE studies. Observational researchers should highlight the level of transparency of their studies by providing a succinct statement addressing study transparency with the publication of every paper, poster, or presentation that reports on a RWE study. In this paper, we propose a framework for an explicit transparency statement that declares the level of transparency a given RWE study has achieved across five key domains 1) protocol, 2) pre-registration, 3) data, 4) code sharing, and 5) reporting checklists.