Collaboration Creates Roadmap in Canada to Report Real-World Evidence Studies

CADTH, Health Canada, and the Institut national d’excellence en santé et en services sociaux (INESSS) are seeking to advance the use of real-world evidence in regulatory and health technology assessment decision-making

A final guidance document published today provides important direction on reporting real-world evidence (RWE) studies in a way that maximizes transparency for regulatory and health technology assessment (HTA) decision-makers in Canada.

Read Guidance for Reporting RWE

RWE is the evidence surrounding the use and potential benefits or risks of a medical product derived from the analysis of real-world data (RWD). RWD are data relating to patient status and/or the delivery of health care collected from a variety of sources and can include electronic medical records, clinical and disease registries, and administrative databases.

Globally, RWE is evolving and playing an increasingly important role in health care decision-making. However, the rapid growth in the volume and types of RWE has created a need for transparent and consistent reporting of RWE studies to inform regulatory and HTA decision-making.

In response to this need, the RWE Steering Committee, co-chaired by CADTH and Health Canada, convened a working group including regulators, HTA organizations, methodologists, and pan-Canadian data holders to develop a foundational guidance document. The document provides a consistent approach for reporting RWE to both regulatory and HTA agencies that aligns with international principles for decision-grade RWE.

The main objectives of the guidance are:

  • To ensure regulators and HTA agencies have sufficient information to evaluate a study for its appropriateness of use to inform 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.

Wide-Ranging Stakeholder Engagement

Extensive stakeholder engagement and consultation were undertaken throughout the development of the guidance document. This included presentations and meetings with regulatory and HTA agency staff, expert and advisory committees, data holders, patient organizations, health care professionals, research networks, academia, pharmaceutical and life sciences industries, commercial RWE providers, and others. A series of workshops, meetings, and public webinars were held followed by an 8-week public consultation period that saw more than 50 organizations submit feedback.

The Response to Stakeholder Feedback Report summarizes the written feedback received and organizes it into 9 major themes. It also describes the processes used to revise the document to arrive at the final Guidance for Reporting Real-World Evidence.

Read the Response to Stakeholder Feedback Report

Next Steps

The guidance document published today represents a first step in laying the foundation for how RWE should be reported in Canada. To build on this foundational work, cross-sector engagement with stakeholders and partners across the health system will continue with a view to operationalize the guidance and enhance the integration of RWE throughout the life cycle of drugs and other health technologies.


The RWE Steering Committee gratefully acknowledges the national and international experts and organizations who contributed their time, energy, expertise, and enthusiasm to the creation of foundational guidance for RWE reporting in Canada.

Quick Facts

  • Support and oversight for this initiative were provided by the RWE Steering Committee, co-chaired by CADTH and Health Canada. This committee includes pan-Canadian health, government, and patient organizations; industry; academia; and data holders. The guidance document was developed by the RWE Steering Committee’s Guidance for Reporting Real-World Evidence Working Group, which includes a Methods Authorship Team, a Leadership Review Team, and an Expert Methods Panel, including Stakeholder Panel members. All members are listed in the guidance report.
  • To develop the guidance, existing international standards and recommendations were leveraged to create an initial draft of core reporting standards. The consensus was established through extensive engagement with national and international experts in RWD and RWE, as well as stakeholders in Canada. A separate feedback report summarizes the feedback received on the preliminary version of the Guidance for Reporting Real-World Evidence document.
  • The guidance document contains a complete list of individuals and organizations involved in the development process.

Related Content

Real-World Evidence for Decision-Making

Health Canada’s position on Guidance for Reporting Real-World Evidence