Canada’s Drug Agency Taking Steps to Expand Access to Real-World Evidence

Canada’s Drug Agency has published a summary report from its time-limited Industry Task Force. The report outlines key actions for the organization, and the broader health care community, that can enable the use of industry-sponsored real-world evidence (RWE) to help improve our understanding of the safety and effectiveness of new treatments.

The time-limited task force represents a first-of-its-kind collaboration between the pharmaceutical industry, Canada’s Drug Agency, and Health Canada. It was established in September 2023 to formally explore sharing industry-sponsored RWE with our Post-Market Drug Evaluation (PMDE) Program. The task force provided a forum for constructive dialogue about how to effectively operationalize the access to and use of industry-sponsored RWE and demonstrates an innovative approach to improving access to data in Canada.

Over the course of 4 meetings, the task force examined issues related to evidence sharing, such as scope, ownership, transparency, operational requirements, privacy, process, and collaboration. The summary report presents the findings from these meetings. It is organized into 6 main themes:
 

• types of RWE that can be shared
• implications of ownership of RWE
• level of transparency (required and acceptable)
• operational requirements and conditions for effective sharing
• implications for the PMDE Program at Canada’s Drug Agency
• collaborative evidence generation for post-market evaluation and decision-making.
   

The report emphasizes early engagement between manufacturers and Canada’s Drug Agency in the PMDE query process and more broadly within the drug life cycle across our organization. It recommends earlier engagement to gather a wider range of evidence, reduce delays in accessing evidence, and identify potential gaps in the evidence during the drug review process to prepare for future post-market needs. The report also provides a rationale for, and suggests who should lead, proposed actions that can help facilitate the use of industry-sponsored RWE.

The summary report does not represent an approved plan, but it will inform the PMDE Program and its Advisory Committee. Our aim is to incorporate some of the proposed actions into the current PMDE query process before the end of the fiscal year.

The PMDE Program offers an ideal platform to test approaches to using this type of industry-sponsored post-market evidence. Since its launch in 2022, the PMDE Program has been operating a network of experienced research partners to deliver evidence about drugs that have been approved for use and are broadly available to people in Canada. The research teams are experts in applied research, scientific methods, and data analysis.

What Is Industry-Sponsored RWE

The pharmaceutical industry is increasingly collecting and sponsoring the generation of real-world data. This includes patient-level data collected outside of traditional clinical trials from a variety of sources (e.g., chart reviews, clinical registries, patient-support programs). RWE is clinical evidence derived from the analysis and synthesis of that real-world data.

Health data are collected, analyzed, and stored in different ways — with different ownership arrangements and needs for patient consent and privacy — which can create barriers to sharing. Despite this, manufacturers are interested in sharing aggregate data and evidence with health technology assessment bodies to expand the evidence that is available to inform policy decisions.

One of the new work streams in the expanded mandate of Canada’s Drug Agency involves increasing pan-Canadian data collection and expanding access to drug and treatment data, including all types of RWE.

Shaping the Pan-Canadian Discussion on RWE

Innovating the use of RWE is a key ambition of Canada’s Drug Agency, as outlined in our strategic plan. Collaboration in this area is essential to reducing barriers to access and bridging evidence gaps across the lifecycle of a product.

Beyond the PMDE Program, we are increasingly incorporating RWE across many of our programs. This includes offering early scientific advice on RWE generation plans and considering relevant types of RWE in our drug reimbursement reviews. We also collaborated with Health Canada and the L’Institut national d’excellence en santé et en services sociaux (INESSS) to deliver guidance on transparent reporting of RWE studies.