Canada’s Drug Agency releases report proposing opportunities and barriers for using industry real-world evidence

Canada’s Drug Agency (formerly CADTH) aims to enhance drug evaluation by integrating real-world evidence (RWE), focusing on data sharing, transparency, and collaboration to refine post-market assessments.

Canada’s Drug Agency has announced progress in integrating RWE into drug evaluation through its recently concluded, time-limited PMDE Industry Task Force. Established in September 2023, this task force was a collaborative effort involving the pharmaceutical industry, Canada’s Drug Agency, and Health Canada. The primary aim was to enhance the post-market drug evaluation (PMDE) Program by incorporating industry-sponsored RWE, with the ongoing collaboration and recommendations outlined in the summary report aimed at refining drug evaluation practices and improving health outcomes in Canada.

---

Key findings and recommendations

The task force, which concluded in April 2024, held four meetings to discuss various aspects of evidence sharing. Key issues addressed included the scope of RWE, ownership rights, transparency, operational requirements, privacy concerns, and collaboration processes. The culmination of these discussions is summarized in the 54-page summary report, released in August 2024, which focuses on six main themes derived from these discussions:

• Types of RWE for sharing: The report explores which forms of RWE can be effectively shared, focusing on patient-level data collected outside traditional clinical trials from diverse sources such as electronic medical records, clinical registries and patient-support programs.
• Implications of ownership: It addresses the complexities of data ownership, privacy, and consent, which pose challenges to data sharing and integration.
• Transparency: The report emphasizes the need for clarity regarding what level of transparency is required and acceptable in the sharing and reporting of RWE.
• Operational requirements: Effective sharing requires streamlined processes and robust privacy measures.
• Implications for the PMDE program: Recommendations include enhancing early engagement between manufacturers and Canada’s Drug Agency to expedite data access and anticipate future needs.
• Collaborative evidence generation: It advocates for a collaborative approach in generating evidence for post-market evaluation and decision-making.

---

Future directions

One of the primary recommendations of the report is to improve early engagement between drug manufacturers and Canada’s Drug Agency. By involving stakeholders earlier in the drug lifecycle, the goal is to reduce delays, fill evidence gaps, and better prepare for future post-market evaluations. Although the summary report does not constitute an approved plan, the aim is for it to be used to guide the PMDE Program and its Advisory Committee in integrating some of these proposed actions by the end of the fiscal year.

The PMDE Program, established in 2022, serves as a critical platform for testing novel approaches to RWE. It utilizes a network of experienced research partners to gather and analyze evidence on drugs approved for use in Canada. These research teams bring expertise in applied research and data analysis, essential for the effective use of RWE.

The push to innovate the use of RWE aligns with Canada’s Drug Agency strategic plan, which emphasizes the importance of collaboration and data access. By incorporating RWE across various programs, including drug reimbursement reviews and early scientific advice, the agency aims to address evidence gaps and enhance policy decisions. Additionally, Canada’s Drug Agency has partnered with Health Canada and L’Institut national d’excellence en santé et en services sociaux (INESSS) to provide guidance on transparent RWE reporting, further supporting the initiative’s objectives.