CADTH: Guidance for Reporting Real-World Evidence
CADTH has partnered with Health Canada, the Institut national d’excellence en santé et en services sociaux (INESSS), and other health system stakeholders to advance the integration of real-world evidence (RWE) into decision-making. Guidance for Reporting Real-World Evidence lays the foundation for the use of RWE in regulatory approval and Health Technology Assessment (HTA) in Canada, starting with the principles for transparent reporting of RWE studies.
CADTH and Health Canada are the co-chairs of the RWE Steering Committee, which includes pan-Canadian health, government, and patient organizations; industry; academia; and data holders. The RWE Steering Committee provided support and oversight for this initiative and received quarterly updates from the Guidance for Reporting Real-World Evidence working group (WG). The Guidance for Reporting Real-World Evidence WG included a Methods Authorship Team, a Leadership Review Team, and an Expert Methods Panel including Stakeholder Panel members in Canada.
The Guidance for Reporting Real-World Evidence document includes a Recommendations Checklist, which can be used as a tool to ensure submissions adhere to the guidelines outlined in the document.
A separate Response to Stakeholder Feedback report outlines the feedback received during the consultation process by theme and responses to feedback, including from regulatory and HTA perspectives.
Read CADTH’s Guidance for Reporting Real-World Evidence document here.