In a recent publication, Wang et al. discuss STaRT-RWE: a tool for reporting real world evidence data. This tool is expected to make study design more robust, reporting more efficient, and to also allow for studies of the effectiveness of medical safety products, among other uses. The authors hope their STaRT-RWE tool will address some of the issues posed by real world studies and consulted with the International Council of Harmonization during the creating of the tool.
According to the authors, “In alignment with the International Council of Harmonization’s strategic goals, a public-private consortium has developed a structured template for planning and reporting on the implementation of real world evidence (RWE) studies of the safety and effectiveness of treatments. The template serves as a guiding tool for designing and conducting reproducible RWE studies; set clear expectations for transparent communication of RWE methods; reduce misinterpretation of prose that lacks specificity; allow reviewers to quickly orient and find key information; and facilitate reproducibility, validity assessment, and evidence synthesis. The template is intended for use with studies of the effectiveness and safety of medical products and is compatible with multiple study designs, data sources, reporting guidelines, checklists, and bias assessment tools.” Learn more here.
(Source: Wang et al., BMJ, 1/12/21)