Introducing CADTH’s RWE Guidance Working Group

CADTH is pleased to announce the introduction of the Real-World Evidence (RWE) Guidance Working Group which reports to the Real-World Evidence Steering Committee. The objective of this Guidance Working Group is to develop clear and comprehensive guidance on the conduct, reporting, and appraising of RWE studies concerning the safety and effectiveness of health technologies for the purpose of regulatory approval and health technology assessment (HTA) in Canada.

Specific Objectives of the RWE Guidance Working Group

1. Leverage the principles and standards in existing guidance documents available globally to develop Canadian-specific guidance that aligns with international standards.
2. Work with national and international experts to establish reporting and quality standards and associated tools concerning the inclusion of real-world data (RWD) in regulatory and HTA decision-making.
3. Work with national and international experts to establish standards and associated tools concerning methods for generating RWD to inform regulatory and HTA decision-making.

To achieve these objectives, the RWE Guidance Working Group will embark on a 3-step process:

Step 1: Guidance Mapping Exercise

The literature review team will leverage the translated Institut national d’excellence en santé et en services sociaux (INESSS) report to conduct an extended environmental scan of all major published guidances and related tools. The team will then map components from all guidance documents into 2 major streams: (1) reporting or submission of RWD for regulatory approval and HTA, and (2) design and methods for generating RWE to inform decision-making.

Step 2: Expert Guidance Development

An online modified Delphi process with an expert panel will be used to obtain expert opinion on which factors to include in the Canadian RWE guidance, and establish standards for reporting and appraising RWE studies. The expert panel will meet 4 times, virtually, between May 2022 and February 2023. After completing the first draft of the guidance, an online Delphi survey will be administered to assist in developing consensus among the panel participants.

Step 3: External Stakeholder Engagement

In line with current CADTH procedures, the draft guidance for public review and feedback will be posted in November 2022. In parallel, CADTH will also host 1 to 2 town halls with various stakeholder groups. All input and discussions must be submitted in writing. The guidance will be presented at the CADTH symposium and other Canadian and international conferences.

RWE Panel Members

This Expert Working Group will include both stakeholder members (end-users and experts) and experts. Experts will be strategically selected to allow for diversity in geography, expertise, and career level

CIHI = Canadian Institute for Health Information; Dhal = Dalhousie Medical School; IHE = Institute of Health Economics; INESSS = Institut national d’excellence en santé et en services sociaux; NDORMS = Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences; NICE = National Institute for Health and Care Excellence; RWE = real-world evidence; UBC = University of British Columbia; UNB = University of New Brunswick.