Development of a Canadian Guidance for reporting real-world evidence for regulatory and health-technology assessment (HTA) decision-making

Abstract

Background and objective: Real-world evidence (RWE) can complement and fill knowledge gaps from randomized controlled trials to assist in health-technology assessment (HTA) for regulatory decision-making. However, the generation of RWE is an intricate process with many sequential decision points, and different methods and approaches may impact the quality and reliability of evidence. Standardization and transparency in reporting these decisions is imperative to appraise RWE and incorporate it into HTA decision-making. A partnership between Canadian health system stakeholders, namely, Health Canada and Canada's Drug Agency (formerly the Canadian Agency for Drugs and Technologies in Health), was established to develop guidance for the standardization of reporting of RWE for regulatory and HTA decision-making in Canada.

Study design and setting: A collaborative initiative to create structured guidance for RWE reporting in the context of regulatory and HTA decision-making.

Results: The developed guidance aims to standardize and ensure transparent reporting of RWE to improve its reliability and usefulness in regulatory and HTA processes.

Conclusion: This guidance can be adapted for other jurisdictions and will have future extensions to incorporate emerging issues with RWE and HTA decision-making.

Keywords: Epidemiologic research design; Guidelines; Health-technology assessment; Observational studies; Pharmacoepidemiology; Publishing standards; Real-world evidence; Regulators.