Development of a Canadian Guidance for reporting real-world evidence for regulatory and health-technology assessment (HTA) decision-making.

Autor: Tadrous M; Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada. Electronic address: Mina.tadrous@utoronto.ca., Aves T; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada., Fahim C; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada., Riad J; Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada., Mittmann N; Sunnybrook Research Institute, Toronto, Canada; Canadian Agency for Drugs and Technologies in Health, Ottawa, Canada., Prieto-Alhambra D; Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands; Medical Informatics Department, Erasmus Universiteit Rotterdam, Rotterdam, The Netherlands., Rivera DR; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, MD, USA., Chan K; Sunnybrook Research Institute, Toronto, Canada., Lix LM; Department of Community Health Sciences, University of Manitoba, Winnipeg, Canada., Kent S; Erasmus School of Health Policy & Management, Erasmus University Rotterdam, The Netherlands., Dawoud D; Science, Policy and Research Programme, National Institute for Health and Care Excellence, London, UK., Guertin JR; Faculty of Medicine, Department of Social and Preventive Medicine, Université Laval, Quebec City, Quebec, Canada., McDonald JT; Department of Political Science, University of New Brunswick, Canada., Round J; Institute of Health Economics, Edmonton, Alberta, Canada; Faculty of Medicine and Dentistry, Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada., Klarenbach S; Faculty of Medicine and Dentistry, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada., Stanojevic S; Department of Community Health and Epidemiology, Dalhousie University, Halifax, Canada., De Vera MA; Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, Canada., Strumpf E; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada., Platt RW; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada., Husein F; Canadian Agency for Drugs and Technologies in Health, Ottawa, Canada., Lambert L; Canadian Agency for Drugs and Technologies in Health, Ottawa, Canada., Hayes KN; Department of Health Services, Policy, and Practice, Brown University School of Public Health, Providence, RI, USA.
Jazyk: angličtina
Zdroj: Journal of clinical epidemiology [J Clin Epidemiol] 2024 Dec; Vol. 176, pp. 111545. Date of Electronic Publication: 2024 Sep 23.
DOI: 10.1016/j.jclinepi.2024.111545
Abstrakt: Background and Objective: Real-world evidence (RWE) can complement and fill knowledge gaps from randomized controlled trials to assist in health-technology assessment (HTA) for regulatory decision-making. However, the generation of RWE is an intricate process with many sequential decision points, and different methods and approaches may impact the quality and reliability of evidence. Standardization and transparency in reporting these decisions is imperative to appraise RWE and incorporate it into HTA decision-making. A partnership between Canadian health system stakeholders, namely, Health Canada and Canada's Drug Agency (formerly the Canadian Agency for Drugs and Technologies in Health), was established to develop guidance for the standardization of reporting of RWE for regulatory and HTA decision-making in Canada.
Study Design and Setting: A collaborative initiative to create structured guidance for RWE reporting in the context of regulatory and HTA decision-making.
Results: The developed guidance aims to standardize and ensure transparent reporting of RWE to improve its reliability and usefulness in regulatory and HTA processes.
Conclusion: This guidance can be adapted for other jurisdictions and will have future extensions to incorporate emerging issues with RWE and HTA decision-making.
Competing Interests: Declaration of competing interest M. T. received financial support from the Canadian Agency for Drugs and Technologies in Health. M. T., T. A., and K. N. H. report a relationship with Canadian Agency for Drugs and Technologies in Health that includes consulting or advisory. N. M., L. L., and F. H. are employed with the Canadian Agency for Drugs and Technologies in Health. There are no competing interests for any other author.
(Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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