STaRT-RWE
STaRT-RWE is a structured template designed to help plan and report real-world evidence studies in healthcare. It ensures that important aspects of the study are considered and clearly communicated, improving transparency and usefulness for decision-making.
At a glance
Use when
Planning or reporting real-world evidence studies for regulatory submission, health technology assessment, or payer decision-making
Avoid when
Conducting simple descriptive analyses without external reporting needs; when time or data constraints prevent thorough completion
Inputs
Study objectives, research questions, target population, data sources, study design, analytical methods, stakeholder input
Outputs
Structured plan or report of an RWE study covering design, methodology, data, limitations, and stakeholder considerations
How it works
STaRT-RWE (Structured Template for Reporting and Planning Real-World Evidence Studies) is a framework developed within the GetReal initiative to support the design and reporting of real-world evidence (RWE) studies in the context of medicine development and regulatory decision-making. It provides a standardized structure to guide researchers in planning RWE studies by addressing key methodological, data, and stakeholder considerations. The template supports alignment between sponsors, regulators, and other stakeholders by promoting comprehensive and transparent study planning.
- Project
- GetReal
- Funding
- IMI
- Project status
- Completed 2021
- HTA domains
- Clinical Effectiveness, Costs & Economic Evaluation, Patient and Social Aspects
- Assumptions
- High-quality real-world data are available; stakeholder engagement improves study relevance; transparency enhances credibility of RWE
- Strengths
- Improves transparency, consistency, and stakeholder alignment in RWE studies; supports regulatory and HTA acceptance of evidence
- Limitations
- Requires detailed input and expertise to complete; may be resource-intensive to implement fully; not a substitute for rigorous methodology
- Also known as
- Structured Template for Reporting and Planning Real-World Evidence Studies
Questions this answers
- › How should a real-world evidence study be planned to meet regulatory and HTA requirements?
- › What key elements should be included when reporting an RWE study?
- › How can transparency and reproducibility be improved in RWE research?
- › How can stakeholder input be integrated into RWE study design?
- › What data sources and methodological considerations are relevant for RWE?
- › How can biases and limitations in RWE be systematically addressed?
References & sources
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Similar by meaning
Beta record. Based on the original catalogue summary; primary-source enrichment pending.