Real-World Evidence for Decision-Making

( Last Updated : March 24, 2023)

Real-World Evidence

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.

Partnerships and Stakeholders

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:

  • The Real- World Evidence Guidance Working Group is developing clear and comprehensive guidance on the conduct, reporting, and appraising of RWE studies concerning the safety and effectiveness of health technologies for regulatory approval and health technology assessment in Canada.
  • The Real-World Evidence Oncology Working Group provides advice and support on the optimal use of RWE for health care decision-making related to oncology therapeutics in Canada and the planning and execution of learning projects.
  • The Real-World Evidence Non-Oncology Working Group provides advice and support on the optimal use of RWE for health care decision-making concerning non-oncology therapeutics in Canada and the planning and execution of learning projects.

CADTH also engages with several types of stakeholder groups to support and provide guidance on the optimal use of RWE. These groups include:

  • commercial RWE service providers
  • private drug plans
  • rare disease research networks and businesses
  • governments
  • health system partners
  • general public
  • patients with rare disease
  • rare disease patient organizations
  • pharmaceutical industry
  • health care professionals
  • rare disease data holders
  • researchers and academics.

Drugs for Rare Diseases

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:

  1. multi-stakeholder engagement and dialogue
  2. real-world data generation and access
  3. collaborative partnerships
  4. guidance for RWE.

Learning Projects

CADTH’s learning projects for RWE fall into the following categories:

Case Studies

CADTH is actively gathering case studies from organizations that generate or integrate RWE into their work, including:

International Initiatives

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