Author: Mina Tadrous, Theresa Aves, Christine Fahim, Jessica Riad, Nicole Mittmann, Daniel Prieto-Alhambra, Donna R. Rivera, Kelvin Chan, Lisa M. Lix, Seamus Kent, Dalia Dawoud, Jason Robert Guertin, James Ted McDonald, Jeff Round, Scott Klarenbach, Sanja Stanojevic, Mary A. De Vera, Erin Strumpf, Robert W. Platt, Farah Husein, Laurie Lambert, Kaleen N. Hayes
Year: 2024
Category:
Health Publications
Health regulators and health-technology assessment (HTA) organizations increasingly use real-world evidence, such as information from health records and registries, to help inform decisions about medical products and health technologies. Because these data are collected during routine care, studies using them can vary widely in how they are designed, analyzed, and reported.
This project brought together Canadian and international experts, along with regulators, HTA organizations, and other stakeholders, to develop a Canadian guidance document for reporting real-world evidence. The guidance was created through a multi-step process that included reviewing existing documents, using expert consensus methods, and gathering public and stakeholder feedback.
The final guidance provides a checklist and explanatory material describing what information should be reported when real-world evidence is included in regulatory or HTA submissions. Its purpose is to support clearer, more transparent reporting so that decision makers can better understand how studies were conducted and how results were produced.
