Generalizability and transportability methods have been proposed to address the external validity bias of randomized clinical trials that results from differences in the distribution of treatment effect modifiers between trial and target populations. However, such studies present many challenges. We review and summarize state-of-the-art methodological considerations. We additionally provide investigators with a step-by-step guide to address these challenges, illustrated through a published case study. When conducted with rigor, such studies may play an integral role in regulatory decisions by providing key real-world evidence.

翻译：为解决随机临床试验的外部有效性偏差,建议了一般性和可运输性方法,这种试验是由于试验对象与目标人群之间在治疗效果改变因素分布上的差异造成的,然而,这种研究提出了许多挑战。我们审查并总结了最先进的方法考虑。我们通过公布的案例研究,为调查人员提供了应对这些挑战的分步骤指南。在进行这种研究时,通过提供现实世界的关键证据,这些研究可以在监管决定中发挥不可或缺的作用。