As real-world evidence (RWE) and real-world data (RWD) increasingly supplement data from randomized controlled trials (RCTs) in regulatory decision-making in Canada, the Canadian Agency for Drugs and Technologies in Health (CADTH) has issued a guidance for RWE reporting. The guidance, published in coordination with the Institut national d’excellence en santé et en services sociaux (INESSS) and Canada Health, will help align RWE and RWD usage with regulatory bodies and health technology assessment (HGA) agencies.
According to Fasken, “The guidance recognizes that operationalization of the recommendations may depend on the context, which will be informed by the diversity of sources of RWD, designs and uses of RWE, and the relevant therapeutic area. CADTH states that the recommendations may be applied flexibly and selectively so as to enable their use for RWE in a variety of contexts. For example, CADTH cites utilization or burden of disease studies, which may not require application of certain recommendations contained in the guidance, and rare diseases and medical devices, which may necessitate flexible application of the recommendations to accommodate for challenges in the generation of RWE in those contexts.”
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(Source: Fasken, June 29th, 2023)