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

Background and Objective: Real-world evidence (RWE) can complement and fill knowledge gaps from randomized controlled to assist in health-technology assessment (HTA) for regulatory decision-making. However, the generation of RWE is an intricate with many sequential decision points, and different methods and approaches may impact the quality and reliability of evidence. ization and transparency in reporting these decisions is imperative to appraise RWE and incorporate it into HTA decision-making. nership between Canadian health system stakeholders, namely, Health Canada and Canada's Drug Agency (formerly the Canadian for Drugs and Technologies in Health), was established to develop guidance for the standardization of reporting of RWE for regulatory HTA decision-making in Canada. Study Design and Setting:A collaborative initiative to create structured guidance for RWE reporting in the context of regulatory andHTA decision-making.Results:The developed guidance aims to standardize and ensure transparent reporting of RWE to improve its reliability and usefulnessin regulatory and HTA processes.Conclusion:This guidance can be adapted for other jurisdictions and will have future extensions to incorporate emerging issues withRWE and HTA decision-making