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We congratulate the authors of this landscape assessment on a comprehensive and stimulating article which carefully reviews many important biostatistical issues related to the use of real-world data (RWD) to support medicine development. In the article, the authors highlight the value of the estimand framework for studies using RWD. We fully support this statement and in what follows we consider the target trial framework as a tool that could be used to both embed the estimand thinking process in studies leveraging RWD and help investigators to critically reflect on whether the RWD are sufficient to address the causal question of interest. We also reflect on several practical issues relevant to studies using RWD that would merit consideration in future work and highlight the need for more published case-studies to guide practitioners working in this setting.

Comment on “Biostatistical Considerations When Using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment”