CADTH Guidance for Reporting Real-World Evidence
This guidance helps researchers and decision-makers clearly report real-world evidence—information gathered from sources outside traditional clinical trials, like patient records or insurance data—so it can be reliably used in health technology assessment and regulatory decisions in Canada.
At a glance
Use when
When preparing real-world evidence for submission to regulatory or HTA bodies in Canada.
Avoid when
When reporting standards are already mandated by other established frameworks incompatible with Canadian guidance.
Inputs
Real-world data and details of analytical methods used in generating real-world evidence.
Outputs
Standardized, transparent reports of real-world evidence suitable for regulatory and HTA review.
How it works
Developed through a collaboration between Health Canada and Canada's Drug Agency (formerly CADTH, now Canada's Drug Agency), this guidance standardizes the reporting of real-world evidence (RWE) to enhance transparency, reliability, and utility in regulatory and HTA decision-making. It addresses methodological decisions in RWE generation and aims to support consistent evaluation across jurisdictions.
- HTA domains
- Clinical Effectiveness, Costs & Economic Evaluation, Safety
- Assumptions
- Transparent reporting improves the credibility and usability of real-world evidence in health decision-making.
- Strengths
- Developed collaboratively by key Canadian health authorities; designed for integration into both regulatory and HTA processes; promotes consistency and trust in RWE.
- Limitations
- Currently specific to the Canadian context; may require adaptation for use in other jurisdictions.
- Also known as
- CADTH RWE Reporting Guidance, Canadian Guidance for Reporting Real-World Evidence
Questions this answers
- › How should real-world evidence be reported to support regulatory decisions?
- › What information is essential for transparent reporting of real-world studies?
- › How can RWE complement evidence from randomized controlled trials in HTA?
- › What methodological choices in RWE generation need to be disclosed?
- › How can standardization improve trust in real-world evidence?
- › What role does reporting clarity play in HTA decision-making?
References & sources
Similar by meaning
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