Article(id=1236700465832981100, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236700465119949418, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1664380800000, acceptedDateStr=2022-09-29, onlineDate=1772781967838, onlineDateStr=2026-03-06, pubDate=1681488000000, pubDateStr=2023-04-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772781967838, onlineIssueDateStr=2026-03-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772781967838, creator=13701087609, updateTime=1772781967838, updator=13701087609, issue=Issue{id=1236700465119949418, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='7', pageStart='657', pageEnd='760', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772781967668, creator=13701087609, updateTime=1772782901622, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236704382474047808, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236700465119949418, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236704382474047809, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236700465119949418, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=719, endPage=723, ext={EN=ArticleExt(id=1236700466088833646, articleId=1236700465832981100, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Interpretation of the "Core Patient-reported Outcomes in Cancer Clinical Trials Guidance for Industry (draft)", columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=

The concept of patient-focused drug development has been paid increasing attention by researchers in China and abroad. Patient-reported outcome (PRO) has gradually become one of the endpoints in clinical trials. PRO provides health information directly from the patient and plays an important role in the clinical decision making by physicians. However, the use of PRO assessment and data interpretation in oncology clinical trials are still waiting for further improvement. The selection of core PRO indicators is critical to the consistency of PRO assessment criteria. In 2021, U.S. FDA issued the "Core Patient-Reported Outcomes in Cancer Clinical Trials Guidance for Industry (draft)" for drug development in cancer clinical trials, providing guidance for sponsors on core PRO collection, PRO assessment tool selection, and standardized trial design. This paper interprets the systematic assessment and application of core PRO in the guideline, helps practitioners of new drug clinical trials to further understand PRO and promotes the implement of PROs in new drug clinical trials in a good way.

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以患者为中心的药物研发理念愈发受到国内外研究者的重视，患者报告结局（patient-reported outcome, PRO）已逐渐成为临床试验的终点观察指标之一。PRO提供直接来自患者的健康信息，在医生的临床决策中起到重要作用。但肿瘤临床试验中PRO评估方法的运用和数据解释还有待改进。核心PRO指标的选用对PRO评估标准的一致性至关重要。2021年美国FDA发布的《肿瘤临床试验运用核心患者报告结局行业指南（草案）》针对肿瘤临床试验的药物研发，为申办方核心PRO收集、PRO评估工具选择和规范化试验设计提供指导意见。本文对该指南核心PRO的系统评估及运用进行解读，帮助新药临床试验从业者进一步了解PRO，对PRO在新药临床试验中的运用起到良好的促进作用。

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刘铭睿，女，硕士研究生，主要从事药理学研究。E-mail: liumr6@mail2.sysu.edu.cn。

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刘铭睿，女，硕士研究生，主要从事药理学研究。E-mail: liumr6@mail2.sysu.edu.cn。

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