Medical device real-world data and evidence in Canada: An environmental scan highlights
- The Health Products and Food Branch (HPFB) at Health Canada is leading an initiative, “Regulatory Review of Drugs and Devices (R2D2)”.
- The Marketed Health Products Directorate (MHPD), within HPFB, is committed to the optimization of the use of real-world data (RWD) and real-world evidence (RWE) and regulations to support regulatory decision-making throughout the medical device life cycle.
- The definitions of RWD and RWE used by Health Canada are as follows: RWD are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources (e.g., data collected from data registries, electronic health records, etc.) and RWE is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD (e.g., information derived from multiple RWD sources)Footnote 1.
- In collaboration with the Pan-Canadian Health Technology Assessment (HTA) Collaborative (PCC)Footnote 2, Health Canada developed a strategy that outlines the activities that Health Canada and the PCC will undertake to optimize the use of RWE across the medical device life cycleFootnote 3.
- An environmental scan was carried out to identify the sources of RWD in Canada and to understand the stakeholder and patient experiences and perceptions related to the use of RWE to assess the safety, clinical effectiveness and cost-effectiveness of medical devices.
- Responses from an online survey were collected from 54 stakeholders on a total of 95 data recording systems related to medical devices, 14 articles on RWD sources for medical devices in Canada were selected for inclusion in the literature review, and 34 telephone interviews with 40 key informants were conducted.
- Key findings in the environmental scan centered on regulatory leadership and support; stakeholder engagement and partnerships; patient engagement; and data collection; quality; and analysis of RWD and applications of RWE.
- The report results do not provide a complete representation of RWD sources for all devices in Canada.
Key findings of environmental scan
Regulatory Leadership and Support
- There are expectations for Health Canada to produce a guidance document that describes the reasons for and appropriate uses of RWE.
- This guidance document should also outline the relevant outcomes for data collection and criteria for data quality, and adopt a more systematic process to conduct post-market surveillance.
- Health Canada should work closely with HTA organizations to develop methods to generate RWE, and a framework that outlines the use of RWE use across the product life cycle.
- Participants identified the federal government as the leader to improve data access across provinces and provide guidance on the use of RWE for submissions on therapeutic devices and in-vitro diagnostic devices.
- Interviewees encouraged Health Canada to spearhead discussions on the development of a national registry of surgical implants, beyond the existing Canadian Joint Replacement Registry.
- Interdisciplinary and international collaborations were deemed as paramount to gain an increased awareness of the perspectives and initiatives in this space.
Stakeholder Engagement and Partnerships
- Early stakeholder engagement and partnerships can facilitate an alignment on the rationale for and identify scenarios on the appropriate use of RWE.
- These engagements and partnerships can ameliorate data collection and facilitate data sharing across provinces and health care organizations.
- There is a lack of awareness of what the regulatory approval process entails, so education and outreach by Health Canada is critical.
- Partnerships with stakeholders can help to increase RWE uptake.
- There are opportunities for partnerships with health care systems, health care providers, clinical societies, patient groups, and industry to work together.
- There is a keen interest to develop a partnership between the federal and provincial governments, where Health Canada would develop a national strategy and the provinces would operationalize it.
- Partnerships with organizations already in the RWD and RWE space can help to leverage their resources to determine the current gaps, study designs, and opportunities for future or long-term label expansions.
- Patients must be involved in the RWD collection and RWE generation and must always be given the option to opt out of data collection at any time without impacting their access to the device.
- There is support from patient representatives, in general, to use RWE to inform decisions related to their care.
- Most patients are willing to share their anonymized or de-identified medical data to researchers, health care providers, government, and patient advocacy groups.
- Knowledge translation may be required to clarify the RWD and RWE terms to patients.
Data Collection, Quality, and Analysis
- Data quality and increased access to several data sources can increase the uptake of RWE in decision-making.
- RWE can help to inform health product development and improvement, and identify opportunities for label expansion.
- Resources and funding necessary for the data collection, maintenance, and sustainability are important considerations.
- Robust scientific methods for RWD analyses employed for RWE generation are necessary to identify the relevant questions and to perform rigorous statistical analyses in order to answer the questions.
- Unique device identifiers are essential in this process.
Applications of RWE
- There is stakeholder support for the use of RWE for pre-market and post-market regulatory decisions and HTA recommendations.
- It is critical to identify when and why the use of RW would be appropriate in each of the product life cycle phases.
- Additional applications of RWE include:
- Assessment of health care provider performance;
- Understanding of patient care pathways and experiences and health resource use;
- Measurement of medical device safety and effectiveness;
- Expansion of patient populations and indications for medical device use; and
- Support new product development, enhanced accessibility, and informed procurement decisions.
HTA=Health technology assessment; IVDDs=In-vitro diagnostic devices; PMS=Post-market surveillance; RWD=Real-world data; RWE=Real-world evidence
- The results of this environmental scan will help to inform the development of a RWE framework across the medical device life cycle as outlined in the joint strategy between Health Canada and the PCC.
- Footnote 1
Center for Devices and Radiological Health, Food and Drugs Administration. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. August 2017; Accessed January 4, 2019
- Footnote 2
Members of the Pan-Canadian Health Technology Assessment Collaborative comprise of Health Quality Ontario, l’Institut national d'excellence en santé et services sociaux, the Institute of Health Economics, the British Columbia Health Technology Assessment Office, and Canadian Agency for Drugs and Technologies in Health.
- Footnote 3
Health Canada and Pan-Canada Health Technology Assessment Collaborative. A Strategy to Optimize the Use of Real-World Evidence across the Medical Device Life Cycle in Canada. 2019.
Report a problem or mistake on this page
- Date modified: