News

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In line with current CADTH procedures, the draft guidance for public review and feedback will be posted in November 2022.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

Canadian members

Organization

Robert Platt   

McGill  

Erin Strumpf   

McGill  

Lisa Lix   

University of Manitoba  

Ted McDonald  

UNB  

Kelvin Chan   

CanREValue  

Scott Klarenbach  

Alberta RWE Consortium  

Jason Guertin  

Laval University  

Jeff Round  

IHE  

Sanja Stanojevic  

Dhal  

Mary De Vera  

UBC  

Erik Dorff

Statistics Canada

Andrew Raven

Health Canada

Catherine Njue

Health Canada

Geneviève Plamondon

INESSS

Sara Beha

INESSS

Tom Samaha

INESSS

Deborah Cohen

CIHI

International members

Organization

Shirley Wang   

Harvard  

Dani Prieto-Alhambra   

Oxford (NDORMS)  

Seamus Kent  

NICE  

Dalia Dawoud  

NICE  

Donna Riveria  

FDA  

Core working team

Organization

Mina Tadrous, Lead

University of Toronto

Kaley Hayes

Brown University

Theresa Aves

Unity Health Toronto

Tina Fahim

Unity Health Toronto

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.