Finding the right tool for the specific task: navigating RWE tools and checklists.

Abstract

Real-world evidence (RWE) is increasingly used to support product approvals and label expansions, as well as clinical and payer decision-making. Various tools (e.g. frameworks, checklists) have been developed to help inform and assess the robustness and quality of real-world study design and reporting. This targeted review provides a practical guide for leveraging these tools to increase awareness and utility for decision-makers. A pre-defined search strategy was applied to identify articles from PubMed. Articles published from 1 January 2020, through 4 October 2024 were included and reviewed to identify relevant tools aimed at assessing RWE study planning, reporting, or quality assessment. Key information regarding each was extracted and summarized including strengths, limitations, and included domains. 119 articles were initially identified, of which 15 were included after screening, referencing a total of 17 tools. These 17 tools varied in format and structure, ranging from detailed guidelines and templates to checklists and questionnaires. Utility and application of the tools identified in this targeted review vary across the evaluation of study planning, reporting, and quality. Selection of the appropriate tool depends on several factors including intended purpose of the tool, intended real-world study design, and the availability of study documentation.