CADTH, on behalf of the Real-World Evidence Steering Committee, has launched a public consultation to solicit feedback on a pan-Canadian guidance document that will inform the use of real-world evidence (RWE) that may be submitted for consideration in regulatory and reimbursement decision-making.
Regulators and health-technology assessment (HTA) agencies have recognized the need to integrate high-quality RWE to help address evidence gaps for decision-making. However, as capacity and expertise in the generation of RWE increase, there is a need to standardize reporting for RWE studies that are submitted to inform regulatory and HTA decision-making.
A key component of CADTH’s 3-year strategic plan is to be a leader in evidence appraisal and to optimize the integration of RWE into our work. Several projects are underway to help us “learn by doing” and deliver on this ambition. Our goals are to facilitate multi-stakeholder dialogue, examine ways to generate and access real-world data, engage in collaborative partnerships, and develop RWE reporting guidance in collaboration with the national and international experts who form the RWE Guidance Working Group. CADTH’s lessons learned will be shared broadly to inform the development of a framework that will optimize the integration of RWE into decision-making.
Opportunities to Provide Feedback
As part of the engagement process, an online consultation opens November 10, 2022, and runs until January 6, 2023. CADTH will also host a webinar for stakeholders on December 2, 2022. The webinar will describe the process used to develop the guidance and the type of feedback that CADTH is seeking. It will also provide a forum for stakeholders to ask questions about the consultation process.
Additionally, in March 2023, CADTH will host a second webinar to summarize and share the type of feedback provided through the consultation process. Individuals and/or organizations who provide feedback through the consultation process will not be identified.