Health Canada’s position on the CADTH Guidance for Reporting RWE to Support Decision-making
Canada’s Drug and Health Technology Agency (CADTH) collaborated with Health Canada and other stakeholders to develop the Guidance for Reporting RWE to Support Decision-making. This guidance promotes the use of high-quality real world data (RWD) and real world evidence (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 are still the main source of evidence for regulatory decision-making, Health Canada recognizes there is value in using RWD/RWE.
We are open to receiving submissions that rely on high-quality RWD/RWE in certain situations, such as:
- expanding evidence-based indications for populations often excluded from clinical trials
- for example, children, older adults and expectant mothers
- addressing diseases where clinical trials are not feasible
- for example, rare diseases
- responding to emergencies where clinical trials are unethical
To support the use of RWD/RWE in regulatory decision-making, we have produced several documents, including:
- Optimizing the use of real world evidence to inform regulatory decision-making
- Elements of real world data/evidence quality throughout the prescription drug product life cycle
The CADTH guidance aligns with the principles outlined in these documents. You may also find reporting templates such as the ISPE-ISPOR HARmonized Protocol Template to Reproducibility (HARPER) and STaRT-RWE helpful in developing high-quality RWE studies.
Regulatory decision-making requires unique considerations beyond the scope of the CADTH guidance. For this reason, we encourage sponsors to engage with us with tangible plans about why and how they will rely on RWD/RWE for a drug submission. We recommend that sponsors consult the following:
- Pre-clinical trial application (CTA) consultation meeting
- Guidance document: The management of drug submissions and applications
The usefulness of RWD/RWE in regulatory decision-making will be determined case by case. We will base our decision on the methodologies used to generate the evidence, as well as the reliability and relevance of the RWD/RWE.
In their submissions, sponsors should:
- indicate clearly where the RWD/RWE fits in with respect to the evidence as a whole and how RWD/RWE addresses any question(s) or gap(s) in the evidence
- justify the reasons for relying on RWD/RWE rather than on conventional clinical trial data
- acknowledge the limitations and potential biases of the underlying RWD/RWE
Health Canada continues to collaborate with domestic and international partners on the use of RWD/RWE in regulatory decision-making and to develop and harmonize RWD/RWE reporting standards.
For any RWD/RWE-related questions or for more information, sponsors may contact us by email at firstname.lastname@example.org.
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