Today, CADTH, on behalf of the Real-World Evidence Steering Committee, 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.
RWE is evidence about the use, safety, and effectiveness of a drug or other health technology that is based on data from the real-world health care setting. Sources of data can include health administrative databases, electronic medical records, patient registries, patient-reported information, and many others. RWE is playing an increasingly important role in global and pan-Canadian regulatory and HTA decision pathways.
Optimizing the use of RWE in decision-making depends heavily on multi-stakeholder dialogue, access to good-quality data, generating and reporting on “fit-for-purpose” RWE, and cross-sector collaboration.
The purpose of the guidance document is to highlight best practices for reporting, as well as important methodological considerations that can help to standardize RWE submissions and maximize their relevance for regulators and HTA bodies in Canada. Importantly, the proposed guidance aligns with existing RWE guidance from international regulators and HTA bodies, while providing strong consideration of the pan-Canadian health care environment.
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.
“As regulatory and reimbursement pathways continue to evolve, real-world evidence is playing an important role in the authorization, value assessment, and post-market supervision of drugs and other health technologies over their life cycle. In Canada, it is imperative that we develop our skills in assessing the evidentiary value of RWE and create shared best practices for reporting RWE studies that reflect the Canadian context. CADTH is grateful to the national and international experts who contributed to this guidance document, and we look forward to refining it based on feedback from a broad range of health system stakeholders.”
Dr. Nicole Mittmann
Chief Scientist and Vice-President, Evidence Standards