Real-World Evidence and Real-World Data Guidance


( Last Updated : July 27, 2022)
Project Line:
Methods and Guidelines

Details


There is increasing interest in the use of real-world data (RWD) to generate real-world evidence (RWE) to complement evidence from randomized clinical trials for the purpose of decision-making. As a result, decision-making bodies are being asked to develop guidance for industry and other stakeholders about standards and processes related to the use of RWD and RWE to support decisions about drug access, reimbursement, and pricing.

As chair of the RWE Steering Committee, CADTH is facilitating the development of clear and comprehensive principles for use of RWE in the Canadian health system context. The RWE Steering Committee includes representation from government, patient organizations, industry, and academia, as well as data holders.

CADTH has commissioned mapping of key concepts and the establishment of an international expert panel to support a collaborative adapted Delphi process for RWE guidance development. There will be opportunity for further stakeholder engagement and feedback on the preliminary document. The final deliverable will be a white paper that provides guidance for the use of RWD and RWE in the Canadian health system.

The RWE Panel is incorporated into the second stage for RWE Guidance development. This will occur from April to November 2022, followed by an opportunity for Stakeholder Feedback before RWE guidance is published by March 2023.

RWE Panel Members

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.