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.

The development of this guidance was founded on the following main objectives:

• to ensure that regulators and HTA agencies have sufficient information to evaluate a study for its appropriateness of use for decision-making
• to provide core reporting standards for RWE studies that align with global standards
• to prioritize transparency in reporting while accounting for practical challenges related to RWD and RWE.

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. This guidance was written in a manner that allows for flexibility in its use for a variety of RWE applications. As such, some recommendations in this document will not apply to all RWE studies. The summary lists of recommendations and the checklist are not intended to replace a careful review of the text, which contains critical information needed to develop adequate reporting. 

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.

For details on Health Canada’s position on Guidance for Reporting Real-World Evidence and related documents to support the use of RWD/RWE in regulatory decision-making, please visit Health Canada’s website.