Last Updated : June 2, 2023
Real-world evidence (RWE) is evidence about the use, safety, and effectiveness of a drug, medical product, or technology based on data from a real-world health care setting. It is playing an increasingly important role in health care policy and practice decision-making.
To learn more about RWE, read CADTH’s Real-World Evidence Primer.
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.
Guidance for Reporting Real-World Evidence
CADTH serves as the Chair of the collaborative Real-World Evidence Steering Committee. The committee is helping to develop a strategic framework for Canada’s use of RWE to support decision-making.
The Real-World Evidence Steering Committee consists of the following working groups:
CADTH also engages with several types of stakeholder groups to support and provide guidance on the optimal use of RWE. These groups include:
CADTH shares with Health Canada the challenge of evaluating drugs for the treatment of smaller populations or rare disease and has recognized the need to develop knowledge, capabilities, and competencies related to RWE to meet this challenge.
During a presentation at the 2021 CADTH symposium entitled Real-World Evidence and Health Technology Assessment: Past, Present, and Future, CADTH launched a learning period to better understand how to optimize the use of RWE to inform decision-making for drugs for rare diseases.
This learning period launched the creation of the Best Brains Exchange (BBE) co-hosted by CADTH, the Canadian Institutes of Health Research (CIHR), and the Canadian Organization for Rare Disorders (CORD). Learnings from the BBE and from subsequent consultations with a variety of health system stakeholders helped CADTH identifying 4 pillars necessary for optimal integration of RWE into decision-making processes.
Development of these 4 pillars and related activities were presented at CADTH’s Information Day in April 2022 and will support optimal integration of RWE into decision-making processes. They are:
CADTH’s learning projects for RWE fall into the following categories:
CADTH is actively gathering case studies from organizations that generate or integrate RWE into their work, including:
CADTH is currently participating in several international RWE and real-world data initiatives, including:
If you have questions about CADTH’s work to support RWE for decision-making, contact us at firstname.lastname@example.org.