Real World Evidence (RWE) 201 – Canada – Health Canada’s position on the CADTH Guidance for Reporting RWE to Support Decision-making

RWE 201 – Canada – Health Canada’s position on the CADTH Guidance for Reporting RWE to Support Decision-making


Health Canada released its position (May 2023) on the Canadian Agency for Drugs and Technologies in Health (CADTH) Guidance for Reporting Real-World Evidence (RWE) to Support Decision-making.

The CADTH RWE guidance, developed in collaboration with Health Canada and other stakeholders, aims to promote the use of high-quality real-world data (RWD) and RWE in drug development and regulatory decision-making. It also emphasizes the importance of transparent and comprehensive reporting of RWE studies to assess reliability and reproducibility.

While traditional clinical trials remain the primary source of evidence for regulatory decision-making, Health Canada acknowledges the value of RWD and RWE.

The agency is open to receiving submissions that rely on high-quality RWD and RWE in certain situations, such as:

  1. Expanding evidence-based indications for populations often excluded from clinical trials, including children, older adults, and expectant mothers
  2. Addressing diseases with limited treatment options or rare conditions
  3. Supporting post-market safety and effectiveness evaluations
  4. Informing the design of future clinical trials

The CADTH guidance provides a framework (and checklist) for reporting RWE studies, which can help researchers and healthcare professionals better understand the potential benefits and limitations of RWE in regulatory decision-making.

By promoting the use of high-quality RWD and RWE, the guidance aims to improve the overall quality of evidence available for drug development and regulatory decisions, ultimately benefiting patients and healthcare systems.

As a real-world evidence researcher or regulatory compliance specialist, you may find this guidance useful in your work, as it can help you provide actionable and engaging insights to researchers and healthcare professionals. By understanding and implementing the CADTH guidance, you can contribute to the development of more effective and efficient regulatory compliance solutions in the field of real-world evidence.

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