On November 10, 2022, among other procedural updates included in the CADTH Pharmaceutical Reviews Update Issue 32, CADTH published its Real-World Evidence (RWE) Steering Committee’s anticipated Proposed RWE Reporting Guidance and initiated a public consultation on the guidance open now through January 6, 2023.

What to know:

• The Guidance document was developed with the support of Canadian and international RWE experts, including representatives from international agencies such as the FDA and NICE.
• The Guidance document’s goal is to provide best practices for reporting and highlight methodological considerations to help standardize RWE submissions and maximize relevance for use by Canadian regulators and HTA organizations.
• The Guidance document is intended to align with existing international guidance, but has 2 key differences:  1)  It is more directly relevant to the Canadian context; and 2) It establishes standards for reporting to both HTA and regulatory agencies, not just one or the other.
• Transparency is a theme reiterated throughout the document as instrumental to providing Canadian regulators and HTA agencies with the information they require to interpret the evidence and inform decision-making.
• The Guidance document is comprehensive, including a submission checklist of 92 items that should be reported on.  The following factors were highlighted as being particularly important:  the study question and design; detailed information on the study setting and context; data sources and rationale for selection of specific sources; details of participant selection and characteristics; clear and justified definitions of the exposures and comparators; valid outcomes that are relevant to the research question; details on the methods used to clean data; reporting on differences between treatment groups and the potential for bias and confounding; statistical methods and precision of effect measures (e.g., confidence intervals); and transparent and accurate reporting of study results and their interpretation.
• It suggests that RWE should not serve as a replacement for clinical trials but to supplement and fill knowledge gaps left by RCTs on the effectiveness, safety, and cost of drugs, medical devices and clinical interventions.
• The document focuses on reporting practices for RWE but does not address other key questions such as when or why RWE should be relied upon and how regulators and HTA bodies intend to implement it for decision-making, which the document indicates are future efforts.

For more information, please see the draft guidelines here. CADTH will also host a webinar on December 2, 2022, explaining the process underpinning the guidelines’ development and provide details about the type of feedback requested.

This initiative stems from CADTH’s 2022-25 Strategic Plan which outlined its work towards RWE being considered in CADTH Reimbursement Reviews and used to inform health system decisions as a goal for the coming years.

This consultation represents an opportunity share perspectives, ask questions and make recommendations on how RWE can contribute to the future of medicine access in Canada.

For further information, please contact Nabil Tadros, Director, Clinical Consulting at Nabil.Tadros@pdci.ca.