Article(id=1291707028154638628, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706987964822180, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.21.024, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1756656000000, receivedDateStr=2025-09-01, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896554268, onlineDateStr=2026-08-05, pubDate=1763308800000, pubDateStr=2025-11-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896554268, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896554268, creator=13701087609, updateTime=1785896554268, updator=13701087609, issue=Issue{id=1291706987964822180, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='21', pageStart='3001', pageEnd='3150', issueExtLink='null', onlineDate='null', pubDate='1763308800000', pubDateStr='2025-11-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896544684, creator='13701087609', updateTime=1785896721343, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291707729324826977, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706987964822180, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291707729324826978, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291706987964822180, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=3143, endPage=3146, ext={EN=ArticleExt(id=1291707028410491173, articleId=1291707028154638628, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Summary and reflection of real-world study cases, columnId=1291339025546211579, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Drug Evaluation and Administration, runingTitle=null, highlight=null, articleAbstract=

In the field of drug development and regulatory science, real-world evidence (RWE) has progressively emerged as a pivotal component. The United States enacted "the 21st Century Cures Act" in December 2016 to encourage Food and Drug Administration (FDA) to leverage real-world evidence, while the European Medicines Agency (EMA) has advanced the development and utilization of RWE through relevant initiatives. In January 2020, China issued the "Guideline on the Use of Real-World Evidence to Support Drug Development and Review," which has significantly catalyzed the advancement of this domain domestically. This paper examines 3 specific cases encompassing retrospective observational studies, prospective randomized controlled trials, and retrospective cohort studies. It systematically analyzes their respective designs and outcomes, delves into the critical statistical elements involved, and provides detailed insights into the associated statistic considerations. Overall, while real-world research is applicable to a wide range of study objectives and designs and plays a vital role in scenarios where randomized controlled trials (RCTs) are challenging to implement, it is also constrained by issues such as variable data quality, potential biases and inadequate standardization. In light of these challenges, the paper underscores the necessity for real-world research to integrate rigorous study design, robust data governance, and advanced statistical methodologies to ensure the scientific reliability and validity of the findings. Particular emphasis is placed on bias control during the design phase, the importance of suitability assessments in data governance, and the centrality of causal inference in statistical analysis. Additionally, it recommends that key statistical issues be carefully considered during protocol development and that alignment be achieved with the Center for Drug Evaluation (CDE) to facilitate the generation of high-quality, evidence-based regulatory decisions.

, authors=Ming-li HENG¹, Si-rui ZHONG², Chen-bo ZHANG¹, Feng-yu SUN¹, authorsList=Ming-li HENG, Si-rui ZHONG, Chen-bo ZHANG, Feng-yu SUN, authorCompany=null, correspAuthors=Ming-li HENG, 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=1291707028691509542, articleId=1291707028154638628, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=真实世界研究案例总结与思考, columnId=1291339025730760957, journalTitle=中国临床药理学杂志, columnName=药物评价与管理, runingTitle=null, highlight=null, articleAbstract=

在药物研发与监管领域，真实世界证据正逐渐成为重要组成部分。美国2016年通过《21世纪治愈法案》鼓励美国食品药品监督管理局运用真实世界证据，欧盟药品管理局也通过相关项目推动真实世界研究发展，我国2020年发布的《真实世界证据支持药物研发与审评的指导原则》促进了国内该领域的发展。本文通过3个具体案例，对包括回顾性观察性研究、前瞻性随机对照研究、回顾性队列研究的设计及结果展开梳理，深入探讨其中的统计学关键内容，并详细说明统计学考虑。总的来说，真实世界研究虽适用于多种研究目的和设计，能在RCTs难以覆盖的场景发挥作用，但也存在数据质量不一、潜在偏倚、标准化不足等局限。基于此，本文强调真实世界研究需结合严谨设计、合理数据治理和先进统计方法，确保结果科学可靠。设计时要重视偏倚控制，数据治理要注重适用性评价，统计分析要以因果推断为核心，同时建议在方案设计时关注关键统计学问题，并与药品审评中心沟通达成一致。

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衡明莉（1980-），女，副研究员，主要从事生物统计学审评工作

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衡明莉（1980-），女，副研究员，主要从事生物统计学审评工作

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