Difficulties in assessing the quality of real-world evidence (RWE) limit its application in regulatory decision-making and clinical development. To this end, a group of experts put together a new tool that provides a standardized approach to RWE quality assessment. In a new interview on The Evidence Base, experts talked about this new tool and the potential impact it may have on the field going forward.
According to Ashley Jaksa, “Thank you for inviting Katsiaryna and I to speak about our ISPOR workshop and the ISPE-lead group project. The purpose of a standardized questionnaire is to help HTA [health technology assessment] bodies to assess the quality of non-randomized RWE studies on medication safety and effectiveness. While several tools that explore the risk of bias exist, these tools often focus primarily on reporting, do not cover all important methodological domains (see D’Andrea et al. 2021), or require substantial expertise in epidemiology. In addition, some HTA reviewers have limited experience in assessing RWE study quality and have noted this as a limitation to RWE use (see Hogervorst et al., 2022). We believe our questionnaire is filling a gap.”
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(Source: The Evidence Base, June 12th, 2023)