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Use of real-world data and evidence for medical devices: a qualitative study of key informant interviews

Published online by Cambridge University Press:  09 November 2020

Julie Polisena Open the ORCID record for Julie Polisena [Opens in a new window]  and
Gayatri Jayaraman
Julie Polisena*
Affiliation:
Health Product Surveillance and Epidemiology Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Health Canada, 200 Eglantine Driveway, Ottawa, OntarioK1A 0K9, Canada International Federation of Medical and Biological Engineering – Health Technology Assessment Division, Ottawa, Ontario, Canada
Gayatri Jayaraman
Affiliation:
Health Product Surveillance and Epidemiology Bureau, Marketed Health Products Directorate, Health Products and Food Branch, Health Canada, 200 Eglantine Driveway, Ottawa, OntarioK1A 0K9, Canada School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, OntarioK1N 6N5, Canada
*
Author for correspondence: Julie Polisena, E-mail: julie.polisena@canada.ca
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Abstract

Introduction

Health Canada is committed to the modernization of the use of real-world data (RWD) and evidence (RWE) to support regulatory decisions. As such, telephone interviews with stakeholders, including government decision makers, health technology assessment (HTA) producers, industry, and patients, to understand their experiences with and perspectives on how to enhance RWE use for medical devices were performed.

Methods

Thirty-four semi-structured telephone interviews with forty key informants were conducted. Transcripts were reviewed independently by one individual to identify, define, and categorize key concepts and were verified by a second reviewer.

Key Findings

There are expectations for Health Canada to provide a framework and guidance on RWE use, identify relevant outcomes for data collection and criteria for data quality, conduct post-market surveillance more systematically, and partner with HTA organizations to develop methods for RWE generation. Stakeholders interviewed support the RWE use for regulatory decisions and HTA recommendations. Moreover, robust scientific methods for RWE generation will be critical to ensure that relevant questions are asked and rigorous statistical analyses are done to answer them. Patients are likely to consent to share their anonymized or de-identified medical information for nonprofit purposes.

Conclusions

Key concepts from the interviews centered on the current and future RWE use for medical devices, considerations for the organizational, medical, scientific, and legal aspects and privacy issues of RWD collection or RWE generation, and options to implement the use of RWD and RWE. Our study findings will help inform the development of an RWE framework for regulatory decisions and HTA recommendations.

Keywords

Real-world dataReal-world evidenceMedical devicesQualitative research
Type
Policy
Information
International Journal of Technology Assessment in Health Care , Volume 36 , Issue 6 , December 2020 , pp. 579 - 584
Copyright
Copyright © The Author(s), 2020. Published by Cambridge University Press

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