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

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.