Summary
STaRT-RWE is a structured template developed to standardise the planning and reporting of real-world evidence studies. The template addresses a recognised gap in methodological guidance for RWE implementation across diverse settings. This work supports transparency, reproducibility, and comparability of real-world evidence research by providing a comprehensive framework for study design and reporting.
UK applicability
This methodology template is directly applicable to UK health research and regulatory contexts, particularly for studies informing medicines safety and efficacy decisions by regulatory bodies such as the MHRA and NHS implementation research.
Key measures
Template components for RWE study planning and implementation reporting; standardisation of RWE study design elements
Outcomes reported
The paper presents STaRT-RWE, a structured template for planning and reporting the implementation of real-world evidence (RWE) studies. It provides guidance on standardising the design, conduct, and reporting of RWE studies across diverse healthcare and research contexts.
Topic tags
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