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Metabolic dysfunction-associated steatohepatitis (MASH) has become a research hotspot for new drug development in the field of liver diseases. Given the complex pathogenesis of MASH, coupled with constraints in disease understanding and therapeutic options, clinical trials are required to involve liver biopsies and prolonged monitoring of clinical outcomes, thereby contributing to the difficulties in drug development. To accelerate the R&D process, an increasing number of new methods and technologies are being developed and explored for application in clinical development of MASH therapeutic drugs. This paper introduces the progress of new methods such as non-invasive tests, optimized clinical trial designs, and artificial intelligence technologies in MASH clinical development, and discusses the challenges encountered in their application to clinical trials.

, authors=Lin LIN, Ying CHEN, authorsList=Lin LIN, Ying CHEN, authorCompany=null, correspAuthors=Ying CHEN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1292126457279566239, articleId=1292126456830775709, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=代谢相关脂肪性肝炎治疗药物临床试验中新方法的应用进展, columnId=1246531408819278046, journalTitle=中国临床药理学杂志, columnName=综述, runingTitle=null, highlight=null, articleAbstract=

代谢相关脂肪性肝炎（metabolic dysfunction-associated steatohepatitis，MASH）临床治疗需求亟待满足，是肝病领域新药的研发热点。MASH发病机制复杂，当前的疾病认知和药物局限，临床试验需要进行肝活检和长期观察临床结局，药物研发难度较高。为加速研发进程，越来越多的新方法、新技术开始被开发和探讨是否可以应用于MASH治疗药物临床研发。本文将介绍MASH临床研发中无创检测、优化临床试验设计、人工智能技术等新方法的相关进展，并探讨应用于临床试验所面临的挑战和解决策略。

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林琳（1992-），女，助理研究员，主要从事药品技术审评工作

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林琳（1992-），女，助理研究员，主要从事药品技术审评工作

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